Sensus Healthcare Annual Report 2018

Plain-text annual report

10K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,0004110K 1 s116712_10k.htm 10KUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10K☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2018OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________Commission File Number: 00137714Sensus Healthcare, Inc.(Exact name of registrant as specified in its charter)Delaware271647271(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)851 Broken Sound Pkwy., NW #215, Boca Raton, Florida33487(Address of principal executive office)(Zip Code)(561) 9225808(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Common Stock, par value $0.01 per shareNasdaq Stock Market, LLCWarrants to Purchase Common Stock (expiring June 8, 2019)Nasdaq Stock Market, LLCSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a wellknown seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ☐ No ☒Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation ST (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes ☒ No ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation SK is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10K or any amendment to this Form 10K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See definitions of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b2 of the Exchange Act.Large accelerated filer ☐Accelerated filer ☐Nonaccelerated filer ☐Smaller reporting company ☒(Do not check if smallerreporting company)If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes ☐ No ☒The aggregate market value of the common equity held by nonaffiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recentlycompleted second quarter, was $58,772,343 based on the closing price of $7.26 per share of common stock on the Nasdaq Capital Market on that date. For thispurpose, all outstanding shares of common stock have been considered held by nonaffiliates, other than the shares beneficially owned by directors, officers andcertain 5% stockholders of the registrant; certain of such persons disclaim that they are affiliates of the registrant.Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.ClassOutstanding at March 8, 2019Common Stock, $0.01 par value per share16,404,820DOCUMENTS INCORPORATED BY REFERENCEPortions of our Proxy Statement for the Annual Meeting of Stockholders to be held on June 7, 2019, are incorporated by reference in Part III.SENSUS HEALTHCARE, INC.ANNUAL REPORT ON FORM 10KTABLE OF CONTENTSPAGEPART IItem 1.Business4Item 1A.Risk Factors15Item 1B.Unresolved Staff Comments35Item 2.Properties35Item 3.Legal Proceedings35Item 4.Mine Safety Disclosure35PART IIItem 5.Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities36Item 6.Selected Financial Data36Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations36Item 7A.Quantitative and Qualitative Disclosure About Market Risk42Item 8.Financial Statements and Supplementary Data43Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure60Item 9A.Controls and Procedures60Item 9B.Other Information61PART IIItem 10.Directors, Executive Officers, and Corporate Governance61Item 11.Executive Compensation61Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters61Item 13.Certain Relationships and Related Transactions, and Director Independence61Item 14.Principal Accountant Fees and Services61PART VItem 15.Exhibits and Financial Statement Schedules62Item 16Form 10K Summary62Signatures632INTRODUCTORY NOTECaution Concerning ForwardLooking StatementsThis Annual Report on Form 10K contains “forwardlooking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject tosignificant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,”“would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forwardlookingstatements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements.In addition to those risks discussed in this Annual Report under Item 1A Risk Factors, factors that could cause our actual results to differ materially from those inthe forwardlooking statements, include, without limitation:●our ability to achieve and sustain profitability;●market acceptance of our products;●our ability to successfully commercialize our products;●our ability to compete effectively in selling our products and services, including responding to technologicalchange and cost containment efforts of ourcustomers;●the regulatory requirements applicable to us and our competitors, including any adverse regulatory action takenagainst us;●our need and ability to obtain additional financing in the future, as well as complying with the restrictions ourexisting revolving credit facility imposes;●our ability to expand, manage and maintain our direct sales and marketing organizations;●our actual financial results may vary significantly from forecasts and from period to period;●our ability to successfully develop new products, improve or enhance existing products or acquire●complementary products, technologies, services or businesses;●our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT100, and our ability toavoid infringing or otherwise violating the intellectual property rights of third parties;●market risks regarding consolidation in the healthcare industry;●the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing fromthird party payors for procedures using our products declines;●the level and availability of government and thirdparty payor reimbursement for clinical procedures usingour products;●our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;●our ability to manufacture our products to meet demand;●our reliance on third party manufacturers and sole or singlesource suppliers;●our ability to reduce the per unit manufacturing cost of our products;●our ability to efficiently manage our manufacturing processes;the regulatory and legal risks, and certain operating risks, that our international operations subject us to;off label use of our products;●information technology risks including the risk from cyberattack;●the fact that product quality issues or product defects may harm our business;the accuracy of our financial statements and accounting estimates, including allowances for accounts receivableand inventory obsolescence;●any product liability claims;●limited trading in our shares and the concentration of ownership of our shares;●cyberattacks and other data breaches and the adverse effect on our reputation;●new legislation, administrative rules, or executive orders, including those that impact taxes and internationaltrade regulation;●the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or thatlimit certain disputes to be brought exclusivelyin the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and3●our ability to manage the risk of the foregoing.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Form 10K also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.PART I.Item 1.BUSINESSOverviewWe are a medical device company that is committed to providing highly effective, noninvasive and costeffective treatments for both oncological and nononcological skin conditions. We use a proprietary lowenergy Xray technology known as superficial radiation therapy (SRT), which is a result of over a decade ofdedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT100TM, SRT100+TM and SRT100VisionTM. To date, SRT technology has been used to effectively and safely treat oncological and nononcological skin conditions in thousands of patients aroundthe world. With the introduction of Sculptura™, we are branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatmentoption for patients around the world.We completed an initial public offering in June 2016 and in February 2018, we opened a wholly owned subsidiary in Israel.Our Products and ServicesSRT100The SRT100 is a photon xray low energy superficial radiotherapy system that provides patients an alternative to surgery for treating nonmelanoma skin cancers,including basal cell and squamous cell skin cancers and other skin conditions such as keloids. The SRT100 is especially effective in treating primary lesions thatwould otherwise be difficult or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner ofthe mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. Superficial radiation therapy treatment procedures do notrequire the use of anesthetics and eliminates the need for skin grafting. We believe that the SRT100 provides healthcare providers and patients with a safe, virtuallypainless, and substantially nonscarring treatment option for nonmelanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retainnonmelanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to costly linear accelerator–basedtreatments with a process that is less invasive, more timeefficient, and improves practice economics. Our revenue is primarily derived from sales of our SRT100product line. The SRT100 provides the following clinical and functional advantages:●Easy touch automatic setup procedure, including automatic xray tube warmup procedures;●Specially designed control console for medical physicists and service technicians which provides integrated safety and backup timer controls, automaticsystem conditioning procedures, calibration, xray output verification and system parameters including last treatment status information;●Advanced patient record management with integrated enterprise workflow management;●Compact mobile design with a small 30” x 30” footprint and unique scissor xray tube arm movements providing a large range of motion for patient accessand treatment; and●High reliability and MTBF (mean time between failures) performance that assure availability for the patients and practitioners and lower the total cost ofownership.4SRT100 VisionThe SRT100 Vision provides customers with additional options compared to the SRT100 base model. These additional options allow for dedicated treatmentplanning and full treatment progression documentation in a patient’s record. The SRT100 Vision provides the user with a unique superficial radiation therapytailored treatment planning application that integrates the embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning,and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patientspecific treatment course to maximizepatient outcomes and workflow efficiency. The SRT100 Vision also offers a comprehensive control console and workflow management that provides full record andtreatment tracing, operatorlevel access and functional control, audiovisual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.SRT100 PlusIn August 2018, we announced the FDA clearance of our SRT100+. The SRT100+ offers all the same features as the SRT100, with the addition of:●An expanded energy range for customized, more precise treatment●Remote diagnostics, including operation tracking●New Xray tube with extended functionality and performance●Advanced console and enhanced system mobility to optimize clinical practiceSculpturaIn February 2019, we announced the FDA clearance of our Sculptura product, which is our proprietary robotic Intraoperative Radiation Therapy (IORT) system thatuses patented Beam Sculpting™ capabilities to treat various cancers during surgery. This system has the potential to give surgeons and radiation oncologists athospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients typically must undergo after surgery and also result insimilar or better outcomes to current radiation treatments today, with significantly less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™, respiratory motion tracking, embedded image guidance and treatment area illumination.Sentinel service programWe offer the Sentinel service program, which provides our customers comprehensive protection for their systems. The Sentinel service program covers all parts andlabor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high voltage loop maintenance, filtersand system cleaning, and system touchups, should they be required during the preventative maintenance session.We also provide turnkey preand postsale services that include the following:●Providing a preinstall kit for the contractors to prepare the treatment room;●Room retrofit and shielding;●System shipping coordination and installation;●System commissioning by a medical physicist (through a national physics network);●System registration with the state and daily workflow documentation preparation;●Clinical applications training with the customer’s superficial radiation therapy staff; and●Treating the first scheduled patients with our customers (onsite applications training).ConsumablesWe sell disposable lead shielding replacements, disposable radiation safety items, such as aprons, and eye shields, and disposable applicator tips, which are used totreat various sized lesions and different areas of the body.5CompetitionThe medical device industry is highly competitive, subject to rapid technological change and is significantly affected by new product introductions and marketactivities of other participants. Our currently marketed products, and any future products we commercialize, will compete against healthcare providers who usetraditional surgical treatment options, such as Mohs surgery, as well as medical device companies that offer other treatment options for the conditions our productsare designed to treat. As of December 31, 2018, we had three primary medical device company competitors:●Xstrahl Medical (headquartered in the United Kingdom and with U.S. headquarters in Georgia)●Xoft (a subsidiary of iCAD, headquartered in New Hampshire)●Elekta (headquartered in Sweden and with U.S. headquarters in Georgia)Xstrahl Medical primarily focuses on clinical and research xray therapy devices and solutions. We believe most of Xstrahl Medical’s installed base is comprised ofhigher energy devices located in Europe.Both Xoft and Elekta offer products that are considered Electronic Brachytherapy (“eBx”) devices. Both eBx products have more limited capabilities than ourproducts as to the size of lesions that can be treated as well as the energy levels that can be used, and require expensive consumables.Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do and may be able to devotegreater resources to the development, promotion, sale and support of their products. Our competitors may also have more extensive customer bases and broadercustomer relationships than we do, including relationships with our potential customers. In addition, many of these companies and healthcare providers have longeroperating histories and greater brand recognition than we do. Because of the size of the markets and the high growth profile of the products in which we compete,other companies may dedicate significant resources to developing competing products. Additionally, we may also face competition from smaller companies thathave developed or are developing similar technologies for our addressable markets. We believe that the principal competitive factors in our markets include:●improved outcomes for medical conditions;●acceptance by doctors treating nonmelanoma skin cancer and keloids;●potential greater acceptance by the patient community;●potential greater ease of use and reliability;●product price and qualification for reimbursement;●technical leadership and superiority;●effective marketing and distribution; and●speed to market.We may be unable to compete effectively against our competitors in regard to any one or all of these factors. Our ability to compete effectively will depend on theacceptance of our products by dermatologists, radiation oncologists, hospitals and patients, and our ability to achieve better clinical outcomes than productsdeveloped by our existing or future competitors. In addition, certain of our competitors could use their superior financial resources to develop products that havefeatures or clinical outcomes similar or superior to our products, which would harm our ability to successfully compete.Sales and MarketingWe focus mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitier sales strategy to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a direct sales force in theU.S., as well as international dealers and distributors. We plan to continue selling and marketing our products to both the dermatology and radiation oncologymarkets concurrently.6Dermatology MarketPrivate dermatology practices in the U.S. represent the point of entry for most nonmelanoma skin cancer patients. We believe the SRT100 offers dermatologists acompetitive advantage by allowing them to retain patients for the treatment of nonmelanoma skin cancer, rather than referring them out to specialists for Mohssurgery or other radiation procedures. In addition to nonmelanoma skin cancers, our FDAapproved indications include, among others, keloids, Kaposi’s Sarcoma,Actinic Keratosis, Metatypic Carcinoma, Cutaneous Appendage Carcinoma and other malignant skin tumors. Our SRT100 is currently being used by over 100 U.S.dermatology practices in the treatment of keloids. Since our clearance in China in July 2017, it is also being used to treat Keloids in China. We are continuing to driveour research and development to expand our indications into new areas of treatment, including psoriasis.Radiation Oncology MarketFor licensed radiation oncologists in the U.S., we believe the SRT100 offers a simpler, faster method of treatment with a better overall patient experience. Our SRT100 system offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providingpatients with effective, noninvasive treatment options for nonmelanoma skin cancer. Our Sculptura system has the potential to give surgeons and radiationoncologists at hospitals and cancer centers the ability to eliminate weeks of postoperative radiation treatments that patients have to undergo after surgery and alsoresult in similar or better outcomes to current radiation treatments today, with much less collateral damage. Sculptura has several exclusive features, including 3DBeam Sculpting™ and respiratory motion tracking to the embedded image guidance and treatment area illumination.Other MarketsWe also believe that both plastic and general surgery markets present growth opportunities for our product offerings. With FDA clearance to treat keloids throughsuperficial radiation therapy, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor.Additionally, we believe that plastic surgeons view the nonmelanoma skin cancer market as a growth opportunity that can supplement their existing services. Webelieve there is an opportunity to also provide superficial radiation therapy in a prophylactic manner for various surgical procedures to reduce the formation ofkeloids. Within the new healthcare reform environment, superficial radiation therapy can provide hospitals and surgery centers with a direct measurable impact onclinical outcomes for certain procedures, including joint replacement procedures, bypass surgery, and OBGYN/Csection procedures, among others.Global FocusAs of December 31, 2018, we had an installed base of 395 units in 17 countries. Our customer list includes leading cancer centers, dermatology practices, hospitalsand plastic surgery clinics, which we believe further validates our targeted marketing approach led by our direct sales teams and our global distribution partners.Manufacturing and SupplyWe currently use a third party located in the U.S. to manufacture our products. In July 2010, we entered into a manufacturing agreement with RbM Services, LLC(“RbM”) pursuant to which RbM agreed to manufacture our SRT100 products. We pay a fixed price per unit under the terms of this agreement, subject to annualadjustments due to changes in the cost of materials. The initial term of this agreement was three years with successive oneyear renewals thereafter. We continue todo business with RbM, although we or RbM may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of eachadditional oneyear renewal period. We believe our third party manufacturer meets FDA, International Organization for Standardization, or ISO, and other qualitystandards. We maintain internal policies, procedures and supplier management processes to ensure that our third party manufacturer is meeting applicable qualitystandards. To date, we have not experienced any difficulty in locating and obtaining the materials necessary to meet the demand for our products, and we believemanufacturing capacity is sufficient to meet global market demand for our products for the foreseeable future.7We believe this third party manufacturing relationship initially allowed us to work with a supplier that has welldeveloped specific competencies while minimizing ourcapital investment, controlling costs and shortening cycle times, all of which we believe allowed us to compete with our competitors. However, we are in the processof adding other third party manufacturers and exploring the possibility of bringing certain manufacturing functions inhouse, which could include the acquisition ofequipment and other fixed assets or the acquisition or lease of a manufacturing facility.We have a single preferred supplier for the xray tubes and other major components used in our products. We believe our preferred suppliers have superiorproducts; however, we also believe that the products of alternate suppliers would be adequate for our products. Although we generally do not have a contractualrelationship with our preferred suppliers we do not anticipate any material disruptions to our supply of major components. We believe that adequate supplies ofmajor components are readily accessible from alternate suppliers.Intellectual PropertyWe actively seek to protect the intellectual property that we believe is important to our business, including seeking and maintaining patents that cover our products.We also rely on trademarks to build and maintain the integrity of our brand.We own two issued U.S. patents. Our patents pertain to technology in the specialized field of superficial radiotherapy treatment. The following patents were issuedbetween August 2007 and September 2008 and were assigned to us when we acquired the technology from Topex:●U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation●U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assemblyThe following patents were issued to us in 2018:●Russia Patent No. 26333322: Hybrid UltrasoundGuided Superficial Radiotherapy System and Method●China Patent No. ZL201380013491.7: Hybrid UltrasoundGuided Superficial Radiotherapy System and MethodA total of 22 patent applications are pending and additional patent applications are in process.We also own three U.S. trademark registrations and currently have eight trademark applications that are pending.We also rely on trade secrets and other unpatented proprietary rights to develop and maintain our competitive position. We seek to protect our unpatentedproprietary rights through a variety of methods, including confidentiality agreements with employees, consultants and others who may have access to ourproprietary information. We also require our employees to execute invention assignment agreements with respect to inventions arising from their employment.No patents or trademarks may ever be issued or registered as a result of our pending or future applications for such intellectual property. Even if any such patents ortrademarks are ultimately issued or registered, they, or any of our other intellectual property, may not provide us with any meaningful protection or competitiveadvantage. Our intellectual property could be challenged, invalidated, circumvented, infringed or misappropriated. In addition, third parties have claimed, and in thefuture may claim, that we, our customers, licensees or other parties indemnified by us are infringing upon their intellectual property rights.Government RegulationOur business is subject to extensive federal, state, local and foreign laws and regulations including those relating to the protection of the environment, health andsafety. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety ofsubjective interpretations. In addition, these laws and their interpretations are subject to change or new laws may be enacted. Both federal and state governmentalagencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. We believe that wehave structured our business operations and relationships with our customers and suppliers to comply with all applicable legal requirements. However, it is possiblethat governmental entities or other third parties could interpret these laws differently and assert otherwise. We discuss below the statutes and regulations that aremost relevant to our business. For the years ended December 31, 2018 and 2017, we incurred approximately $1,039,000 and $866,000, respectively, in expenses relatedto regulatory compliance and quality standards.8U.S. Food and Drug Administration (FDA) Regulation of Medical DevicesThe Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended forhuman use. Our products include medical devices that are subject to these, as well as other federal, state, and local laws and regulations. FDA is responsible for theoverall enforcement of quality, regulatory and statutory requirements governing medical devices. Our regulated medical devices include our SRT100 product line.FDA classifies medical devices into one of three classes — Class I, Class II, or Class III — depending on their level of risk and the types of controls that arenecessary to assure device safety and effectiveness. The class assignment determines the type of premarketing submission or application, if any, that will berequired before marketing in the U.S. Our devices are Class II devices under the FDA’s classification system.●Class I devices present a low risk and are not lifesustaining or lifesupporting. The majority of Class I devices are subject only to “general controls” —e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. Generalcontrols are baseline requirements that apply to all classes of medical devices.●Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety andeffectiveness. Devices in Class II are subject to both general controls and “special controls” — e.g., special labeling, compliance with industry standards,and postmarket surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification(510(k)) process, in accordance with 21 CFR, Part 807 requirements.●Class III devices present the highest risk. These devices generally are lifesustaining, lifesupporting, or for a use that is of substantial importance inpreventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls,by themselves, are insufficient and for which there is insufficient information to establish special controls to provide a reasonable assurance of safety andeffectiveness. Class III devices are subject to general controls and typically require approval of a premarket approval application, or PMA, in accordancewith 21 CFR, Part 814, before marketing.Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially distributedin the U.S. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. With the enactment of the Food and DrugAdministration Safety and Innovation Act, or the FDASIA, the availability of a de novo pathway was facilitated for certain low to moderaterisk devices that do notqualify for the 510(k) pathway due to the absence of a predicate device.510(k) pathwayAs of December 31, 2018, all of our products were subject to the 510(k) requirement or are exempt from the 510(k) requirement. The 510(k) review process compares anew device to an existing legally marketed device. Through the 510(k) process, the FDA determines whether the new medical device is “substantially equivalent” tothe existing legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed new device:(a) has the same intended use as the predicate device; (b) has the same or similar technological characteristics as the predicate device; (c) has supportinginformation submitted in the 510(k) demonstrates that the proposed device is as safe and effective as the predicate device; and (d) does not raise different questionsof safety and effectiveness than the predicate device.To obtain 510(k) clearance, we must submit a 510(k) application containing sufficient information and data to demonstrate that our proposed device is substantiallyequivalent to a legally marketed predicate device. This data generally includes nonclinical performance testing (e.g., software validation, bench testing electricalsafety testing), but may also include clinical data. Typically, it takes approximately four months for the FDA to complete its review of a 510(k) submission; however, itcan take significantly longer and clearance is never assured. During its review of a 510(k), the FDA may request additional information, including clinical data, whichmay significantly prolong the review process. After completing its review of a 510(k), the FDA may issue an order, in the form of a letter, that finds the device to beeither (1) substantially equivalent to the predicate device and states that the device can be marketed in the U.S., or (2) not substantially equivalent to the predicatedevice and states that device cannot be marketed in the U.S. Depending upon the reasons that the FDA finds the new device to not be substantially equivalent tothe predicate device, the device may need to be approved through the PMA pathway (discussed below) prior to commercialization. A new medical device for whichthere is no substantially equivalent device is automatically designated a Class III device. Depending on the nature of the new device, the manufacturer may requestthe FDA to make a riskbased determination of the new device and to reclassify it as a Class I or Class II device. This process is referred to as the de novo process. Ifthe FDA agrees, the new device will be reassigned to the appropriate other class. If the FDA does not agree, the manufacturer must submit a PMA prior tocommercialization. We have received FDA 510(k) clearances for our SRT100 and SRT100 Vision.9After a device receives 510(k) clearance, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a majorchange in its intended use, including significant modifications to any of our products, requires a new 510(k) clearance. The FDA relies on each manufacturer to makeand document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. We have made and planto continue to make minor product enhancements that we believe do not require new 510(k) clearances. However, we expect to confer with the FDA on plannedchanges that may require a special, abbreviated or traditional 510(k) submission. If the FDA disagrees with our determination regarding whether a new 510(k)clearance was required for these modifications, we may need to cease marketing or recall the modified device. The FDA may also subject us to other enforcementactions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution.Premarket approval pathwayAs of December 31, 2018, we did not market any devices that were subject to PMA requirements. Unlike the 510(k) pathway, the PMA approval process requires anindependent demonstration of the safety and effectiveness of a device before the device can be commercialized. PMA is the most stringent type of device marketingapplication required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the deviceis safe and effective for its intended use. A PMA application generally includes extensive information about the device including the results of clinical testingconducted with the device and a detailed description of the manufacturing process.After a PMA application is accepted for review, the FDA begins an indepth review of the submitted information. FDA regulations provide 180 days to review thePMA and make a determination; however, the review time is typically longer (e.g., 1 – 3 years). During this review period, the FDA may request additionalinformation or clarification of information already provided. Also during the review period, an advisory panel of experts from outside of the FDA may be convenedto review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that thedevice is safe and effective for its intended use. In addition, the FDA generally will conduct a preapproval inspection of the manufacturing facility to ensurecompliance with the Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurancerequirements for the design and manufacturing of a medical device.Based on its review, the FDA may (1) issue an order approving the PMA, (2) issue a letter stating the PMA is “approvable” (e.g., minor additional information isneeded), (3) issue a letter stating the PMA is “not approvable,” or (4) issue an order denying PMA. A device subject to PMA review cannot be marketed until theFDA issues an order approving the PMA. As part of a PMA approval, the FDA may impose postapproval conditions intended to ensure the continued safety andeffectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinicaldata. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval.Most modifications to a PMA approved device, including changes to the design, labeling, or manufacturing process, require prior approval before beingimplemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’stime for review of a PMA supplement vary depending on the nature of the modification.10Clinical trialsClinical trials of medical devices in the U.S. are governed by the FDA’s Investigational Device Exemption regulation, in accordance with 21 CFR, Part 812. Thisregulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial,submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control thedisposition of the investigational device, submit required reports, etc.Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing,mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board approval prior to starting the trial.FDA approval is obtained through submission of an Investigational Device Exemption application. Clinical trials of nonsignificant risk devices (i.e. devices that donot meet the regulatory definition of a significant risk device) only require Institutional Review Board approval before starting. The clinical trial sponsor isresponsible for making the initial determination of whether a clinical study is significant risk or nonsignificant risk; however, a reviewing Institutional Review Boardor the FDA may review this decision and disagree with the determination.An Investigational Device Exemption application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showingthat it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of anInvestigational Device Exemption will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if,among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk.As noted above, the FDA may require a company to collect clinical data on a device in the postmarket setting. The collection of such data may be required as acondition of PMA approval. FDA also has the authority to order, via a letter, a postmarket surveillance study, in accordance with 21 CFR, Part 822, for certaindevices at any time after they have been cleared or approved. We do not expect to launch clinical trials subject to the Investigational Device Exemption regulationsfor future products. Also, our products are not currently subject to any required postmarket surveillance studies.Pervasive and continuing FDA regulationAfter a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.These include:●Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807;●Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820;●Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products foruncleared or unapproved, i.e., “offlabel,” uses;●Medical Device Reporting regulation, which requires that manufacturers and importers report to FDA if their device may have caused or contributed to adeath or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21CFR, Part 803; and●Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to FDA recalls (i.e., corrections or removals) ifundertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers andimporters must keep records of recalls that they determine to be not reportable, in accordance with 21 CFR, Part 806.11The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in enforcementaction by FDA, which may include, but is not limited to, the following sanctions:●Issuance of Form 483 observations during a facilities inspection;●Untitled letters or warning letters;●Fines, injunctions and civil penalties;●Consent Decree, which forces improvements in the quality management system through the use of the federal courts;●Recall or seizure of our products;●Operating restrictions, partial suspension or total shutdown of production;●Refusing our request for 510(k) clearance or premarket approval of new products;●Withdrawing 510(k) clearance or premarket approvals that are already granted; and●Criminal prosecution.We are subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance withapplicable state public health regulations. These inspections may include our suppliers’ facilities.InternationalInternational sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market ourproducts in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required toobtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The EuropeanUnion/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, NewZealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as China, Brazil, Canada and Japan require separate regulatoryfilings.In the EEA, our devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC). Compliance with theserequirements entitles us to affix the CE marking of conformity to our medical devices, without which they cannot be commercialized in the EEA. To demonstratecompliance with the essential requirements and obtain the right to affix the CE marking of conformity we must undergo a conformity assessment procedure, whichvaries according to the type of medical device and its classification. Except for low risk medical devices (Class I), where the manufacturer can issue an ECDeclaration of Conformity based on a selfassessment of the conformity of its products with the essential requirements of the Medical Devices Directive, aconformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited by a Member State of the EEA to conductconformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devicesbefore issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up an EC Declaration of Conformitywhich allows us to affix the CE mark to our products.Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical DevicesDirective, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEAMember State laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products tothe general public and may impose limitations on our promotional activities with healthcare professionals.We have obtained approval to sell our products in Europe, China, Canada, Israel, Russia and Mexico, and we are currently seeking approval in several othercountries.12Sales and Marketing Commercial ComplianceFederal antikickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for underfederal healthcare programs such as the Medicare and Medicaid programs. Possible sanctions for violation of these antikickback laws include monetary fines, civiland criminal penalties, exclusion from Medicare and Medicaid programs and forfeiture of amounts collected in violation of such prohibitions.In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government,or knowingly making, or causing to be made, a false statement to get a false claim paid. Offlabel promotion has been pursued as a violation of the federal falseclaims laws. Pursuant to FDA regulations, we can only market our products for cleared or approved uses. Although surgeons are permitted to use medical devicesfor indications other than those cleared or approved by FDA based on their medical judgment, we are prohibited from promoting products for such offlabel uses.Additionally, the majority of states in which we market our products have similar antikickback, false claims, antifee splitting and selfreferral laws, which may applyto items or services reimbursed by any third party payor, including commercial insurers, and violations may result in substantial civil and criminal penalties.To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has increased its scrutiny of interactions between healthcare companies andhealthcare providers which has led to an unprecedented level of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing withinvestigations can be time and resourceconsuming. Additionally, if a healthcare company settles an investigation with the DOJ or other law enforcement agencies,the company may be required to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement.The U.S. and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry,including increased U.S. government oversight and enforcement of the Foreign Corrupt Practices Act. Whenever a governmental authority concludes that we arenot in compliance with applicable laws or regulations, that authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain orseize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees and canrecommend criminal prosecution. Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of devices we distribute.Additionally, the commercial compliance environment is continually evolving in the healthcare industry as some states, including California, Massachusetts andVermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration tophysicians. The Affordable Care Act also imposes reporting and disclosure requirements on device manufacturers for any “transfer of value” made or distributed toprescribers and other healthcare providers. Device manufacturers are also required to report and disclose any investment interests held by physicians and theirfamily members during the preceding calendar year. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 peryear (and up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests not reported inan annual submission. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply in multiple jurisdictionswith different compliance or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.Healthcare Fraud and AbuseHealthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or mostother federally funded healthcare programs. The federal AntiKickback Statute prohibits unlawful inducements for the referral of business reimbursable underfederally funded healthcare programs, such as remuneration provided to physicians to induce them to use certain tissue products or medical devices reimbursableby Medicare or Medicaid. The AntiKickback Statute is subject to evolving interpretations. For example, the government has enforced the AntiKickback Statute toreach large settlements with healthcare companies based on sham consultant arrangements with physicians. The majority of states also have antikickback lawswhich establish similar prohibitions that may apply to items or services reimbursed by any third party payor, including commercial insurers. Further, recently enactedamendments to the Affordable Care Act, among other things, amend the intent requirement of the federal antikickback and criminal healthcare fraud statutes. Aperson or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that thegovernment may assert that a claim including items or services resulting from a violation of the federal antikickback statute constitutes a false or fraudulent claim forpurposes of the false claims statutes. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and ourofficers and employees could be subject to severe criminal and civil penalties including, for example, exclusion from participation as a supplier of product tobeneficiaries covered by Medicare or Medicaid. In addition to the AntiKickback Statute, the federal physician selfreferral statute, commonly known as the StarkLaw, prohibits physicians who have a financial relationship with an entity, including an investment, ownership or compensation relationship, from referring Medicarepatients for designated health services, which include clinical pathology services, unless an exception applies. Similarly, entities may not bill Medicare or any otherparty for services furnished pursuant to a prohibited referral. Many states have their own selfreferral laws as well, which in some cases apply to all third partypayors, not just Medicare and Medicaid. If a governmental authority were to conclude that we are not in compliance with the Stark Law or state selfreferral laws andregulations, our pathology laboratory business could be subject to severe financial consequences, including the obligation to refund amounts billed to third partypayors in violation of such laws, civil penalties and potentially also exclusion from participation in government healthcare programs like Medicare and Medicaid.The Stark Law often is enforced through lawsuits brought under the Federal False Claims Act, violations of which trigger significant monetary penalties and trebledamages.13Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of thegovernment. Violations of the False Claims Act can result in very significant monetary penalties and treble damages. The federal government is using the FalseClaims Act, and the accompanying threat of significant liability, in its investigations of healthcare providers and suppliers throughout the country for a wide varietyof Medicare billing practices, and has obtained multimillion and multibillion dollar settlements in addition to individual criminal convictions. Given the significantsize of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ andsuppliers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.Health Information PrivacyThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and ClinicalHealth Act of 2009, or HITECH, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans andhealthcare clearinghouses, known as covered entities, as well as their business associates that perform services for them that involve individually identifiable healthinformation. The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards withrespect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect theconfidentiality, integrity and security of protected health information.We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and securityregulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and securityregulations and varying state privacy and security laws. In addition, for healthcare data transfers from other countries relating to citizens of those countries, wemust comply with the laws of those other countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, withoutpatient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policypurposes and other permitted purposes outlined in the privacy regulations. HIPAA, as amended by HITECH, provides for significant fines and other penalties forwrongful use or disclosure of protected health information in violation of the privacy and security regulations, including potential civil and criminal fines andpenalties. If we do not comply with existing or new laws and regulations related to protecting the privacy and security of health information, we could be subject tomonetary fines, civil penalties or criminal sanctions. In addition, other federal and state laws that protect the privacy and security of patient information may besubject to enforcement and interpretations by various governmental authorities and courts resulting in complex compliance issues. For example, we could incurdamages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of confidential health information or other privatepersonal information. If we were to experience a breach of protected health information, we could be subject to significant adverse publicity in addition to possibleenforcement sanctions and civil damages lawsuits. Finally, we may be required to incur additional costs related to ongoing HIPAA compliance as may be necessaryto address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations,emerging cybersecurity threats and other factors.14Research and DevelopmentResearch and development costs relate to our products under development and quality and regulatory costs and are expensed as incurred. During the years endedDecember 31, 2018 and 2017, we incurred research and development expense of approximately $6.3 million and $5.5 million, respectively. Most of the increase in R&Dspending in 2018 was related to the development of a device for intraoperative radiation therapy (IORT) for the treatment of breast and other cancers, for which wefiled a 510(k) application with the U.S. Food and Drug Administration (FDA) in December 2017.EmployeesAs of December 31, 2018, we had 48 employees, including 45 in the U.S. and three in Israel. None of our employees are represented by a labor union or covered by acollective bargaining agreement. We consider our relationship with our employees to be good.WebsiteOur filings with the SEC are available free of charge through our website www.sensushealthcare.com. The information on our website is not incorporated byreference into this report.Item1A.RISK FACTORSAn investment in our common stock contains a high degree of risk. You should consider carefully the risks and uncertainties described below before making aninvestment decision. Our business could be harmed if any of these risks, as well as other risks not currently known to us or that we currently deem immaterial,materialize. The trading price of our common stock could decline due to the occurrence of any of these risks, and you may lose all or part of your investment. Inassessing the risks described below, you should also refer to the other information contained in this Annual Report on Form 10K, including our consolidatedfinancial statements and the related notes and schedules, and other filings with the SEC. This Annual Report on Form 10K also contains forwardlookingstatements that involve risks and uncertainties that could cause our actual results to differ materially from those discussed in this Annual Report on Form 10K.These risks and uncertainties include the following:Risks Related to our BusinessWe have a history of net losses. If we do not achieve profitability, our financial condition and the value of our common stock could suffer.We have a history of net losses. Our historical losses from inception through December 31, 2018 totaled approximately $13.5 million. If our revenue grows moreslowly than currently anticipated, or if operating expenses are higher than expected, we may be unable to achieve profitability, our financial condition will suffer andthe value of our common stock could decline. Even if we are successful increasing our sales, we may incur losses in the foreseeable future as we continue toresearch and develop and seek regulatory approvals for our products. If sales revenue from any of our currently cleared products or any additional products thatreceive marketing clearance from the FDA or approval from other regulatory authorities in the future is insufficient, or if our product development is delayed, we maybe unable to achieve profitability. Furthermore, even if we are able to achieve profitability, we may be unable to sustain or increase such profitability on a quarterly orannual basis, which would significantly reduce the value of our common stock.15If thirdparty payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used andour revenue will be negatively impacted.In the U.S., the commercial success of our existing products and any future products will depend, in part, on the extent to which governmental payors at the federaland state levels, including Medicare and Medicaid, private health insurers and other thirdparty payors provide coverage for and establish adequate reimbursementlevels for procedures using our products. The existence of coverage and adequate reimbursement for our products and related procedures by government andprivate payors is critical to market acceptance of our existing and future products. Neither hospitals nor physicians are likely to use our products if they do notreceive adequate reimbursement payments for the procedures using our products.Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center of Medicare and Medical Services, orCMS, which administers the Medicare program and works in partnership with state government to administer the Medicaid program. Others may adopt differentcoverage or reimbursement policies for procedures performed using our products, while some governmental programs, such as Medicaid, have reimbursementpolicies that vary from state to state, some of which may not pay for our products in an amount that supports our selling price, if at all. A Medicare national or localcoverage decision denying coverage for any of the procedures performed with our products could result in private and other thirdparty payors also denyingcoverage. Medicare (part B) and a number of private insurers in the U.S. currently cover and pay for both nonmelanoma skin cancer and keloid treatments using theSRT100. A withdrawal, or even contemplation of a withdrawal, by CMS, Medicaid or private payors of reimbursements, or any other unfavorable coverage orreimbursement decisions by government programs or private payors, could have a material adverse effect on our business.Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtainedon a countrybycountry basis. In many international markets, a product must be approved for reimbursement before it can be cleared for sale in that country.Further, many international markets have governmentmanaged healthcare systems that control reimbursement for new devices and procedures. In most marketsthere are private insurance systems as well as governmentmanaged systems. Our products may not be considered costeffective by international thirdparty payorsor governments managing healthcare systems. Furthermore, reimbursement may not be available or, if available, thirdparty payors’ reimbursement policies mayadversely affect our ability to sell our products profitably. If sufficient coverage and reimbursement are not available for our current or future products, in either theU.S. or internationally, the demand for our products and, consequently, our revenues will be adversely affected.Substantially all of our revenue is generated from the sale of our SRT100 and related products, and any decline in the sales of these products or failure to gainmarket acceptance of these products will negatively impact our business, financial condition and results of operations.We have focused heavily on the development and commercialization of a limited number of products for the treatment of nonmelanoma skin cancer and other skinconditions with superficial radiotherapy. From our inception in 2010 through December 31, 2018, substantially all of our revenue has been derived from sales of ourSRT100 product line and related services and ancillary products. Although we intend to introduce new products, we expect most of our 2019 revenue to be derivedfrom or related to sales of our SRT100 product line. If we are unable to achieve and maintain significantly greater market acceptance of superficial radiotherapy fortreatment of nonmelanoma skin cancer and other skin conditions, or if we do not achieve sustained positive cash flow, then we will be severely constrained in ourability to fund our operations. In addition, if we are unable to market our SRT100 product line and ancillary products as a result of a quality problem, shortage ofcomponents required for assembly, failure to maintain or obtain regulatory approvals, unexpected or serious complications or other unforeseen negative effectsrelated to the SRT100 product line and ancillary products, we would lose our only source of revenue, and our business, financial condition and results of operationswill be adversely affected.16We may be unable to manufacture our products in quantities sufficient to meet existing demand levels, which would hinder our ability to effectivelycommercialize our products and increase revenues.The manufacture of medical devices requires significant expertise and capital investment, including the development of advanced manufacturing techniques andprocess controls, from us and our key suppliers, to scale up the production process to manufacture sufficient quantities at high volume and with satisfactoryproduction yields. Manufacturers of medical devices often encounter difficulties in production, particularly when scaling up initial production. These problemsinclude difficulties with production costs and yields, quality control and assurance, and shortages of qualified personnel, as well as compliance with strictlyenforced federal, state and foreign regulations. In July 2010, we entered into a manufacturing agreement with an unrelated third party for the manufacturing andproduction of the SRT100 in accordance with our specifications. We continue to do business with the manufacturer pursuant to this agreement, although we or themanufacturer may terminate the agreement upon 90 days’ written notice or upon at least 60 days’ notice prior to the end of each additional oneyear renewal period.As discussed elsewhere in this Annual Report on Form 10K, we are in the process of adding another contract manufacturer and are exploring the possibility ofbringing certain manufacturing capabilities inhouse. However, if eventually implemented, our plan to bring the manufacturing function inhouse may not besuccessful and we may be unable to maintain a relationship with our current manufacturer or establish a relationship with another manufacturer on favorable terms, ifat all.Consequently, we may be able to continue to efficiently manufacture our products in sufficient quantities to meet projected demand or to establish sufficientworldwide inventory to fully support our distribution network. Any of these results could cause us to be unable to effectively commercialize our products orincrease revenue, adversely affecting our business, financial condition, results of operations and the value of our common stock.We have a single preferred supplier for the xray tubes and other major components used in our products and the loss of this preferred supplier could adverselyaffect us.We have a single preferred supplier for the xray tubes and other major components used in our products. Although other suppliers exist in the market, we believethat our preferred supplier’s products are of a superior quality. The loss of these preferred suppliers, or their inability to supply us or our third party manufacturerwith adequate components could hinder our ability to effectively produce our products to meet existing demand levels, especially if we were unable to timelyprocure them from other suppliers in the market, which could adversely affect our ability to commercialize our products and increase our revenues.We may be unable to retain and develop our U.S. sales force and nonU.S. distributors, which would adversely affect our ability to meet our revenue targets andother goals.As we launch products, increase current sales efforts and expand into new geographic areas, we will need to retain, grow and develop our direct sales personnel,distributors and agents. There is significant competition for sales personnel experienced in relevant medical device sales. In addition, the training process is lengthybecause it requires significant education for new sales representatives to achieve an acceptable level of clinical competency with our products. Upon completion oftraining, sales representatives typically require lead time in the field to develop or expand their network of accounts and achieve the productivity levels we expectthem to reach in any individual territory. If we are unable to attract, motivate, develop, and retain a sufficient number of qualified sales personnel, or if the salesrepresentatives do not achieve the productivity levels expected, our revenue will not grow as expected, and our financial performance will suffer.In addition, we may not succeed in entering into and maintaining productive arrangements with an adequate number of distributors outside of the U.S. that aresufficiently committed to selling our products in international markets. The establishment and maintenance of a distribution network is expensive and timeconsuming. Even if we engage and maintain suitable relationships with an adequate number of distributors, they may not generate revenue as quickly as we expectthem to, commit the necessary resources to effectively market and sell our products, or ultimately succeed in selling our products. Moreover, if our sales force anddistributors are unable to attract and retain new customers, we may be unable to achieve our expected growth, and our business could suffer. Furthermore, some ofour distributors may market or sell the products of our competitors. In these cases, the competitors may have the ability to influence the products that ourdistributors choose to market and sell, for example, by offering higher commission payments, or by convincing the distributors to terminate their relationships withus, carry fewer of our products or reduce their sales and marketing efforts for our products. Any of the foregoing would hinder our ability to meet our revenuetargets and other goals.17The future worldwide demand for our current products and our future products is uncertain. Our current products and our future products may not be acceptedby hospitals, physicians or patients, and may not become commercially successful.Physicians and hospitals may not perceive the benefits of our products and may be reluctant or unwilling to adopt our products as a treatment option, particularly inlight of existing treatment options, such as Mohs surgery or high dose rate brachytherapy. Additionally, physicians and hospitals may not be aware of thesignificant advances in technology associated with superficial radiation therapy compared to older technology that was previously used with orthovoltage. Whilewe believe that our products are an efficient and less invasive alternative to other treatments of nonmelanoma skin cancer and other skin conditions, physicianswho are accustomed to using other modalities to treat patients with either nonmelanoma skin cancer, keloids or other skin conditions may be reluctant to adoptbroad use of our superficial radiotherapy products.We must grow markets for our products through physician education and awareness programs. Publication in peerreviewed medical journals of results from studiesusing our products will be an important consideration in their adoption by physicians and in reimbursement decisions of thirdparty payors. The process ofpublication in leading medical journals is subject to a peerreview process. Peer reviewers may not consider the results of studies of our products and any futureproducts sufficiently novel or worthy of publication. Failure to have studies of our products published in peer reviewed journals may adversely affect adoption ofour products.Educating physicians and hospitals on the benefits of our products and advancements in superficial radiation technology requires a significant commitment by ourmarketing team and sales organization. Our products may not become widely accepted by physicians and hospitals. If we are unable to educate physicians andhospitals about the advantages of our products, do not achieve significantly greater market acceptance of our products, do not gain momentum in our salesactivities, or fail to significantly grow our market share, we will be unable to grow our revenue, and our business and financial condition will be adversely affected.We are in a highly competitive market segment, which is subject to rapid technological change. If our competitors are able to develop and market products thatare more effective, less costly, easier to use or otherwise more attractive than any of our products, our business will be adversely impacted.The medical device industry is highly competitive and subject to technological change. In the arena for technology and products for use in the treatment of nonmelanoma skin cancer and other skin conditions, we have three primary competitors, one of which operates in the superficial radiotherapy space largely in theEuropean market, and the other two of which operate in the brachytherapy space in both the U.S. and internationally. While we believe our SRT100 and relatedproducts currently have certain competitive advantages over the products offered by these competitors, our success depends, in part, upon our ability to maintainthis competitive position. If these competitors improve their existing products, develop new products, or expand their operations, we may be unable to maintain ourcompetitive advantages over these competitors.Furthermore, new competitors, including companies larger than us, may enter the market in the future and may offer products with similar or alternativefunctionalities. These companies may enjoy several advantages relative to us, including:●greater financial and human resources for product development, sales and marketing;●greater name recognition;●longestablished relationships with physicians and hospitals;●the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;●more established distribution channels and sales and marketing capabilities; and●greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtainingregulatory clearance or approval for products and marketing cleared products.18Hospitals, physicians and investors may not view our products as competitive with other products that are marketed and sold by new competitors, including muchlarger and more established companies. Our competitors may develop and patent processes or products earlier than we do, obtain regulatory clearance or approvalsfor competing products more rapidly than us or develop more effective, more convenient or less expensive products or technologies that render our technology orproducts obsolete or less competitive. If our existing or new competitors are more successful than us in any of these matters, our business may be harmed.Our customers are concentrated in the U.S. and China, and economic difficulties or changes in the purchasing policies or patterns of our customers in thesecountries could have a significant impact on our business and operating results.Substantially all of our 2018 and 2017 sales were made to customers located in the U.S., however in previous years significant sales were made to customers locatedin China. For the years ended December 31, 2018 and 2017, approximately 1% and 2%, respectively, of our product sales were to Chinese customers, withsubstantially the remainder of our sales to customers in the U.S. Additionally, a single customer in the U.S. accounted for approximately 71% and 59% of revenuesfor the years ended December 31, 2018 and 2017, respectively. Because of our geographic and customer concentrations, our revenue could fluctuate significantlydue to changes in economic conditions, the use of competitive products, or the loss of, reduction of business with, or less favorable terms within, these countries orthis customer. A reduction or delay in orders for our products from these countries and this customer could materially harm our business and results of operations.Our future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will beaccepted by the market in a timely manner, and if we do not do so, our results of operations will suffer.It is important to our business that we continue to build a pipeline of product offerings for the treatment of nonmelanoma skin cancer and other skin conditions toremain competitive. Consequently, our success will depend in part on our ability to develop and introduce new products. However, we may be unable tosuccessfully maintain our regulatory clearance for existing products, or develop, obtain and maintain regulatory clearance or approval for product enhancements, ornew products, or these products may not be accepted by physicians or the payors who financially support many of the procedures performed with our products.The success of any new product offering or enhancement to an existing product will depend on several factors, including our ability to:●identify and anticipate physician and patient needs properly;●develop and introduce new products or product enhancements in a timely manner;●avoid infringing the intellectual property rights of third parties;●demonstrate the safety and efficacy of new products with data;●obtain the necessary regulatory approvals for new products or product enhancements;●comply fully with U.S. Food and Drug Administration and applicable foreign government agencies’ regulations on marketing of new devices or modifiedproducts;●provide adequate training to potential users of our products; and●receive coverage and adequate reimbursement for procedures performed with our products.If we do not develop new products or product enhancements and obtain regulatory approval in time to meet market demand, if there is insufficient demand for theseproducts or enhancements, or if competitors introduce new products with enhanced functionalities that are superior to those of ours, then our results of operationswill suffer.Our products may become obsolete prior to the end of their anticipated useful lives, and we may be required to dispose of existing inventory or write off thevalue or accelerate the depreciation of these assets, each which would materially and adversely impact our results of operations.We focus on continual product innovation and product improvement. While we believe this provides a competitive edge, it also creates a risk that our products willbecome obsolete prior to the end of their anticipated useful lives. If we introduce new products or nextgeneration products prior to the end of the useful life of aprior generation, we may be required to dispose of existing inventory, or write off the value of these assets, each of which would materially and adversely impact ourresults of operations.19Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems, and if one or morecompetitors join us in the market, our marketing efforts and ability to compete would be materially and adversely affected.Our success is dependent in large part on our being an early reentrant into the market for our proprietary superficial radiotherapy systems. If one or morecompetitors join us in the market, the increased competition would require us to devote substantial additional resources to our marketing efforts, and our ability tocompete may be severely impaired.Our international operations subject us to certain operating risks, which could adversely impact our results of operations and financial condition.The sale and shipment of our products across international borders, as well as the purchase of components from international sources, subjects us to U.S. andforeign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and exposes us to penaltiesfor noncompliance. Other laws and regulations that can significantly impact us include various antibribery laws, including the U.S. Foreign Corrupt Practices Act,and antiboycott laws, as well as export control laws. Any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways thatinclude, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of exportprivileges, seizure of shipments, restrictions on certain business activities and exclusion or debarment from government contracting. Also, the failure to comply withapplicable legal and regulatory obligations could result in the disruption of our shipping and sales activities. Any of the foregoing would adversely impact ourresults of operations and financial condition.Our international operations and our international distributors expose us to risks inherent in operating in foreign jurisdictions. These risks include, withoutlimitation:●difficulties in enforcing or defending intellectual property rights;●pricing pressure that we may experience internationally;●a shortage of highquality sales people and distributors;●thirdparty reimbursement policies that may require some of the patients who are treated with our products to directly absorb medical costs or that maynecessitate the reduction of the selling prices of our products;●disadvantage to competition with established business and customer relationships;●the imposition of additional U.S. and foreign governmental controls or regulations;●economic instability;●changes in duties and tariffs, license obligations and other nontariff barriers to trade;●the imposition of restrictions on the activities of foreign agents, representatives and distributors;●potentially adverse tax consequences;●laws and business practices favoring local companies;●difficulties in maintaining consistency with our internal guidelines;●the imposition of costly and lengthy new export licensing requirements;●the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibitcontinued business with the sanctioned country, company, person or entity; and●the imposition of new trade restrictions.If any of these events or circumstances were to occur, our sales in foreign countries would be harmed and our results of operations would suffer.20Our U.S. business could be adversely affected by changes in international trade regulation.Both the Trump Administration and certain members of the U.S. Congress have indicated that they may seek to impose importation tariffs on products from certaincountries such as China and Mexico or to impose additional taxes on imported goods generally. Certain countries have publicly stated that they would respond inkind to any such action by the U.S. The Trump Administration recently imposed tariffs on solar panels and washing machines. Any future escalation ofprotectionist trade measures could increase the prices of products, components and supplies that we source internationally, as well as adversely affect our ability tosell our products in foreign markets. In addition, the Trump Administration has appointed and employed many new public officials into positions of authority in theU.S. Federal government dealing with the healthcare industries that may potentially have a negative impact on the prices and the regulatory pathways for certainhealthcare products such as those developed, marketed and sold by us. Such changes in the regulatory pathways could adversely affect and or delay our ability tomarket and sell our products in the U.S. and internationally.Our operating results may vary significantly from quarter to quarter, which may negatively impact the value of our securities.Our quarterly revenues and results of operations may fluctuate due to the following reasons, among others:●physician and hospital acceptance of our products;●the timing, expense and results of research and development activities, and obtaining future regulatory approvals;●fluctuations in expenses associated with expanding operations;●the introduction of new products and technologies by competitors;●sales representatives’ productivity;●supplier, manufacturing or quality problems with products;●the timing of stocking orders from distributors;●changes in our pricing policies or in the pricing policies of competitors or suppliers; and●changes in thirdparty payors’ reimbursement policies.Because of these and other related or similar factors, it is likely that in some future period our operating results will not meet expectations. Failure to meet or exceedanalyst expectations could cause a decrease in the trading price of our securities.We may be unable to attract and retain highly qualified personnel, which could adversely and materially affect our competitive position.Our future success depends on our ability to attract and retain our executive officers and other key employees. We may be unable to attract or retain qualifiedmanagement and other key personnel in the future due to the intense competition for qualified personnel among companies in the medical device business andrelated industries, particularly in the South Florida area where we are headquartered. The medical device industry has experienced a high rate of turnover ofmanagement personnel in recent years. Consequently, we could have difficulty attracting or retaining experienced personnel and may be required to spendsignificant time and expend significant financial resources in our employee recruitment and retention efforts. Many of the other medical device companies withwhich we compete for qualified personnel have greater financial and other resources and risk profiles different from ours. They also may provide more diverseopportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than that which we mayoffer. If we are unable to attract and retain the necessary personnel to accomplish our business objectives, we may have difficulty implementing our businessstrategy and achieving our business objectives.Product liability claims could damage our reputation and adversely affect our business.The design, manufacture and marketing of medical devices each carry an inherent risk of product liability claims and other damage claims. In addition to the exposurewe may have for defective products, physicians may misuse our products or use improper techniques, regardless of how well trained, potentially leading to injuryand an increased risk of product liability. A product liability or other damages claim, product recall or product misuse could require us to spend significant time andmoney in litigation, regardless of the ultimate outcome, or to pay significant damages and could seriously harm our business.21We maintain liability insurance coverage that management believes to be reasonable based on our business and operations; however, our insurance may not besufficient to cover all claims made against us. Our insurance policies generally must be renewed on an annual basis. We may be unable to maintain or increaseinsurance on acceptable terms or at reasonable costs. A successful claim brought against us in excess, or outside of, our insurance coverage could seriously harmour financial condition or results of operations.We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.Our operations have consumed substantial amounts of cash since inception, and we anticipate that our expenses will increase as we continue to grow our business.We may need to seek additional capital in the future. Our growth will depend, in part, on our ability to develop variations of the SRT100 and other products, andrelated technology complementary to our products. Our existing financial resources, including our existing revolving line of credit, may not allow us to conduct all ofthe activities that we believe would be beneficial for our future growth.We may need to seek funds in the future. Our existing revolving line of credit restricts our ability to incur certain indebtedness or permit certain encumbrances onour assets without the prior written consent of the lender. If we are unable to raise funds on favorable terms, or at all, we may not be able to support ourcommercialization efforts or increase our research and development activities or meet our debt and other contractual obligations, and the growth of our businessmay be negatively impacted. As a result, we may be unable to compete effectively.Our cash requirements in the future may be significantly different from our current estimates and depend on many factors, including:●the results of commercialization efforts for products;●the need for additional capital to fund development programs;●the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;●the establishment of highvolume manufacturing and increased sales, marketing and distribution capabilities; and●success in entering into collaborative relationships with other parties.We may be unable to raise funds on favorable terms, or at all, and either case would materially and adversely affect our ability to implement our strategy and meetour goals.To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest will be diluted. Moreover, theterms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, mayinvolve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures ordeclaring distributions or dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability todeclare dividends on our common stock and to achieve our product development and commercialization goals and have a material adverse effect on our business,financial condition and results of operations.Our revolving credit facility imposes substantial restrictions on us, some of which could hinder our ability to conduct our operations effectively or otherwise inaccordance with our business plan.Our revolving credit facility contains a number of negative covenants that require us to seek the lender’s prior written consent in order to conduct certain activities.For example, we may not, without the prior written consent of the lender:●Sell or otherwise transfer all or any part of our business or property, except for transfers in the ordinary course of business or as otherwise permitted by thefacility agreement;●Change the nature of our business, liquidate or dissolve, undergo a change in management;22●Add any new offices or business locations, including warehouses;●Change our jurisdiction of organization, our organizational structure or type, our legal name or any organizational number assigned to us;●Merge or consolidate with any other person or entity or acquire all or substantially all of the capital stock or property of another person or entity;●Create, incur or be liable for any indebtedness other than as permitted by the facility agreement;●Create, incur, or suffer any lien on any of our property (including receivables) other than as permitted by the facility agreement;●Maintain any operating or deposit or security accounts other than with the lender or any of its affiliates;●Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock, except that we may pay dividends solely in commonstock; or●Directly or indirectly make any investment, including, without limitation, by the formation of any subsidiary, other than as permitted by the facilityagreement.In the event we wish to conduct any of the foregoing activities and the lender refuses to provide its prior written consent, our ability to conduct our operationseffectively and in accordance with our business plan could be materially and adversely affected.If we fail to properly manage our anticipated growth, our business could suffer.Our strategy involves substantial growth. If we experience periods of rapid growth and expansion, our limited personnel, operational infrastructure and otherresources could be significantly strained. In particular, the possible internalization of manufacturing, and continued expansion of our direct sales force in the U.S.will require significant management, financial and other supporting resources. In addition, in order to manage expanding operations, we will need to continue toimprove our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable tomanage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer. Any failure by us tomanage our growth effectively could have an adverse effect on our ability to achieve our goals. To achieve our revenue goals, we must successfully increaseproduction output to meet projected customer demand. We may be unable to increase output on the timeline anticipated, if at all. Also, we may in the futureexperience difficulties with production yields and quality control, component supply, and shortages of qualified personnel, among other problems. These problemscould result in delays in product availability and increases in expenses. Any delay or increased expense could adversely affect our ability to increase revenues.Costcontainment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales andprofitability.In an effort to reduce costs, many hospitals or physicians within the U.S. and abroad are members of group purchasing organizations and integrated deliverynetworks. Group purchasing organizations and integrated delivery networks negotiate pricing arrangements with medical device companies and distributors andoffer the negotiated prices to affiliated hospitals, physicians and other members. Group purchasing organizations and integrated delivery networks typically awardcontracts on a categorybycategory basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of drivingdown pricing or reducing the number of vendors. Due to the highly competitive nature of the group purchasing organizations and integrated delivery networkscontracting processes, we may be unable to obtain or maintain contract positions with major group purchasing organizations and integrated delivery networks.Furthermore, the increasing leverage of organized buying groups may reduce market prices for our products, thereby reducing our profitability.While having a contract with a group purchasing organizations or integrated delivery networks for a given product category can facilitate sales to members of thatgroup purchasing organizations or integrated delivery networks, expected sales levels may not be achieved, as sales are typically made pursuant to purchase orders.Even when a provider is the sole contracted supplier of a group purchasing organization or integrated delivery network for a certain product category, members ofthe group purchasing organization or integrated delivery network generally are free to purchase from other suppliers. Furthermore, group purchasing organizationsand integrated delivery networks contracts typically are terminable without cause by the group purchasing organizations or integrated delivery networks upon 60 to90 days’ notice. Accordingly, even if we obtain contracts with any group purchasing organizations or integrated delivery networks, the members of these groupsmay choose to purchase from our competitors due to the price or quality offered by competitors, which could result in a decline in our sales and profitability.23We depend on information technology systems to operate our business and a cyberattack or other breach of these systems could have a material adverse effecton our business.We rely on information technology systems to process, transmit and store electronic information in our daytoday operations. Our information technology systemscould be vulnerable to a cyberattack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption. Any successful attacks couldresult in the theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information or disrupt ouroperations. Cyberattacks are becoming more sophisticated and frequent, and our systems could be the target of malware and other cyberattacks. We have investedin our systems and the protection of our data to reduce the risk of an intrusion or interruption, and we monitor our systems on an ongoing basis for any current orpotential threats.However, these measures and efforts may not prevent interruptions or breakdowns, and we may otherwise fail to maintain or protect our information technologysystems and data integrity effectively. Furthermore, we may fail to anticipate, plan for or manage significant disruptions to our systems. If any of the foregoing wereto occur, our competitive position could be harmed, we could lose existing customers, have difficulty preventing, detecting and controlling fraud, have disputes withcustomers, specialist physicians and other healthcare professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of adata breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results ofoperations, financial condition or cash flows.Consolidation in the healthcare industry could adversely affect our future revenues and operating income.The medical technology industry has experienced a significant amount of consolidation, resulting in companies with greater market presence. Health care systemsand other health care companies are also consolidating, resulting in greater purchasing power for these companies. As a result, the disruption in the healthcareindustry caused by consolidation may lead to further competition among medical device suppliers to provide goods and services, which could adversely affect ourfuture revenues and operating income.We may engage in acquisitions, mergers, strategic alliances, and joint ventures that could result in final results that are different than expected.In the normal course of business, we engage in discussions relating to possible acquisitions, equity investments, mergers, strategic alliances, and joint ventures.Such transactions are accompanied by a number of risks, including the use of significant amounts of cash, potentially dilutive issuances of equity securities,incurrence of debt on potentially unfavorable terms as well as impairment expenses related to goodwill and amortization expenses related to other intangible assets,the possibility that we may pay too much cash or issue too many of our shares as the purchase price for an acquisition relative to the economic benefits that weultimately derive from such acquisition, and various potential difficulties involved in integrating acquired businesses into our operations.If we do not realize the expected benefits of such transactions, our financial position, results of operations, cash flows and stock price could be negatively impacted.Risks Related to our Regulatory EnvironmentWe are subject to various federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with these laws and regulations couldhave a material adverse effect on our business.Our operations are, and will continue to be, directly and indirectly affected by various federal, state and foreign healthcare laws, including, but not limited to, thosedescribed below.●Federal AntiKickback Statute (42 U.S. Code §1320a7b), which prohibits any person or entity from knowingly and willfully offering, paying, soliciting orreceiving any remuneration, directly or indirectly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or arranging for orrecommending the referring, ordering, purchasing or leasing of any good, facility, item or service, for which payment may be made, in whole or in part, underfederal healthcare programs, such as the Medicare and Medicaid programs.24●Federal “Sunshine” (42 U.S. Code §1320a7h) law, which requires us to track and report annually to CMS information related to certain payments and other“transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and toreport annually to CMS ownership and investment interests held by physicians, and their immediate family members. We are also subject to similar foreign“sunshine” laws or codes of conduct, which vary country by country.●Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, persons or entities from knowinglypresenting, or causing to be presented, a false or fraudulent claim to, or the knowing use of false records or statements to obtain payment from, or approvalby, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of thegovernment and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines orsettlement. When an entity is determined to have violated the False Claims Act (31 U.S. Code §37293733), it may be required to pay up to three times theactual damages sustained by the government, plus civil penalties for each separate false claim. Many of the physicians that use our products will file forreimbursement from governmental programs such as Medicare and Medicaid. As a result, we may be subject to the False Claims Act if we knowingly“cause” the filing of false claims.●Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, statute, which, among other things, created federal criminal laws thatprohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly andwillfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with thedelivery of or payment for healthcare benefits, items or services.Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and applicable implementing regulations,impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization onentities subject to the law, such as health plans, clearinghouses, and healthcare providers and their business associates. Internationally, substantially everyjurisdiction in which we operate has established its own data security and privacy legal framework with which we must comply, including the Data ProtectionDirective 95/46/EC and national implementation of the Directive in the member states of the European Union.Many states have also adopted laws similar to each of the above federal laws, such as antikickback and false claims laws, which may be broader in scope and applyto items or services reimbursed by any thirdparty payor, including commercial insurers, as well as laws that restrict our marketing activities with healthcareprofessionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to healthcare professionalsand entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. Additionally, certain states require a certificate ofneed prior to the installation of a radiation device, such as the SRT100. We are also subject to foreign fraud and abuse laws, which vary by country.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we maybe subject to penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, individual imprisonment, contractual damages,reputational harm, exclusion from governmental healthcare programs, and the curtailment or restructuring of our operations. Any of the foregoing could adverselyaffect our ability to operate our business and our financial results.25Our products are subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improvedproducts.Our products must comply with regulatory requirements imposed by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Servicesand other governmental agencies in the U.S., and similar agencies in foreign jurisdictions. These requirements involve lengthy and detailed laboratory and clinicaltesting procedures, sampling activities, an extensive agency review process, and other costly and timeconsuming procedures. It often takes several years to satisfythese requirements, depending on the complexity and novelty of the product. If we execute on our plans to move our manufacturing function inhouse, we will alsobe subject to additional licensing and regulatory requirements relating to safe working conditions, manufacturing practices, environmental protection, fire hazardcontrol, and disposal of hazardous or potential hazardous substances. Some of the most important requirements applicable or potentially applicable to us include:●U.S. Food and Drug Administration Regulations (Title 21 CFR, Parts 801, 803, 806, 807 and 820);●EU CE marking of conformity requirements depicted within the MDD (Directive 90/425/EEC);●Health Canada requirements (SOR/98282);●Medical Device Quality Management System requirements (ISO 13485:2003);●Occupational Safety and Health Administration requirements;●China CFDA requirements; and●Other similar quality, regulatory and statutory requirements in foreign jurisdictions in which we currently market or plan to market our products in thefuture.Additionally, due to the nature of our products as radiation producing medical devices, we are also subject to certain state laws and regulations related to the sale ofour products. Although we have taken steps to ensure our compliance with such state laws and regulations, our failure to fully comply with these requirementscould result in fines or penalties and could also adversely affect our ability to sell our products.Government regulation may impede our ability to the manufacture our existing and future products. Government regulation also could delay the marketing of newproducts for a considerable period of time and impose costly procedures on activities. The U.S. Food and Drug Administration and other regulatory agencies maynot clear or approve any future products on a timely basis, if at all. Any delay in obtaining, or failure to obtain, these approvals could negatively impact themarketing of any future products and reduce our product revenues. Regulatory bodies may review products once they are on the market and determine that they donot satisfy applicable regulatory requirements. Failure to comply with requisite requirements may lead to European Economic Area regulatory bodies ordering thesuspension or withdrawal of products from the European Economic Area market or, as discussed below, notified bodies withdrawing certificates of conformity fordevices or the underlying quality systems.Further, regulations may change, and any additional regulation could limit or restrict our ability to use any of our technologies, which could harm our business. Wecould also be subject to new international, federal, state or local regulations that could affect our research and development programs and harm our business inunforeseen ways.Product deficiencies could result in field actions, recalls, substantial costs or writedowns; which could lead to the delay or termination of ongoing trials, ifany, and harm our reputation, business or financial results.Our products are subject to various regulatory guidelines and involve complex technologies. The U.S. Food and Drug Administration and similar foreigngovernmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacturethat could affect patient safety. Manufacturers may, under their own initiative, conduct a product notification or recall to inform physicians of changes toinstructions for use or if a deficiency in a device is found or suspected.Identified quality problems, such as failure of critical components, or the failure of third parties to supply us with sufficient conforming quantities of these productsor components, could impact the availability of our products in the marketplace or lead to adverse clinical events. In addition, product improvements or productredundancies could result in scrapping or expensive rework of products, and our business, financial condition or results of operations could suffer as a result.Product complaints, quality issues and necessary corrective and preventative actions could result in communications to customers or patients, field actions, requirethe scrapping, rework, recall or replacement of products, result in substantial costs or writeoffs, or harm our business reputation and financial results. Further, theseevents could adversely affect our relationships with our customers or affect our reputation, which could materially adversely affect our earnings, results andfinancial viability.A future field action or recall announcement could harm our reputation with customers, negatively affect our sales, and subject us to U.S. Food and DrugAdministration (or similar governmental authority) enforcement actions. Moreover, depending on the corrective action we take to redress a product’s deficiencies ordefects, the U.S. Food and Drug Administration (or similar governmental authority) may require, or we may decide, that we will need to obtain new approvals orclearances for the product before we market or distribute the corrected product. Seeking these approvals or clearances may delay our ability to replace the recalledproducts in a timely manner. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action,including U.S. Food and Drug Administration (or similar governmental authority) warning letters, product seizures, injunctions, administrative penalties, or civil orcriminal fines.26Any identified quality issue can both harm our business reputation and result in substantial costs and writeoffs, which in either case could materially harm ourbusiness and financial results.The offlabel use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, or result incostly investigations and regulatory agency sanctions under certain circumstances.The products we currently market in the U.S. have been cleared by the U.S. Food and Drug Administration for specific indications. Our clinical support staff andmarketing and sales force have been trained not to promote our products for uses outside of the cleared indications for use, known as “offlabel uses.” However, if aphysician uses our products outside the scope of the cleared indications, there may be increased risk of injury to patients. Furthermore, the use of our products forindications other than those cleared by the U.S. Food and Drug Administration may not effectively treat the conditions associated with the offlabel use, whichcould harm our reputation in the marketplace among physicians and patients, adversely affecting our operations.If the U.S. Food and Drug Administration determines that our promotional materials or training constitute promotion of an offlabel or other improper use, it couldrequest that we modify our training or promotional materials, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, awarning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our business activities to constitute promotion of an offlabel use, which could result in significant penalties, including, but not limited to, criminal,civil or administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of ouroperations. Any of these events could significantly harm our business and results of operations.The advertising and promotion of our products is subject to European Economic Area Member States governing the advertising and promotion of medical devices.In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general publicand may impose limitations on promotional activities with healthcare professionals. These regulations or codes may limit our ability to affectively market ourproducts, or we could run afoul of the requirements imposed by these regulations, causing reputational harm, imposing potentially substantial costs, and adverselyaffecting our operations as a result.We are required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with ourproducts, which can result in voluntary corrective actions or agency enforcement actions.Under the U.S. Food and Drug Administration medical device reporting regulations (21 CFR 803), medical device manufacturers are required to submit information tothe U.S. Food and Drug Administration when they receive a report or become aware that a device has or may have caused or contributed to a death or serious injuryor has or may have a malfunction that would likely cause or contribute to death or serious injury if the malfunction were to recur. All manufacturers placing medicaldevices on the market in the European Economic Area are legally bound to report any serious or potentially serious incidents involving devices they produce or sell(MEDDEV 2.121) to the Competent Authority in whose jurisdiction the incident occurred through the European Vigilance process.If an event subject to medical device reporting requirements occurs, we will need to comply with the reporting requirements, which would adversely affect ourreputation and subject us to actions by regulatory authorities, such as ordering recalls, imposing fines, or seizing the affected products. Furthermore, any correctiveaction, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from operating our business. Any of theforegoing would further harm our reputation and financial results.27Healthcare policy changes may have a material adverse effect on our business.The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, a deductible 2.3%excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S., with limited exceptions, effective January 1, 2013. This excise taximposed a significant increase in the tax burden on the medical device industry. This excise tax was repealed in 2018. Other elements of this law, includingcomparative effectiveness research, an independent payment advisory board, payment system reforms including shared savings pilots and other provisions, maysignificantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs,any of which may materially affect numerous aspects of our business.Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for proceduresutilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affectour revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect onour business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments fromprivate payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to increase revenue, attainprofitability, or commercialize our devices. In addition, other legislative changes may be enacted or existing regulations, guidance or interpretations may be changed,each of which may adversely affect our operations.Risks Related to our Intellectual PropertyIf our patents and other intellectual property rights do not adequately protect our products, we may lose market share to competitors and be unable to operateour business profitably.Our success significantly depends on our ability to protect our proprietary rights to the technologies used in our products. We rely on the patent protection of twoU.S. patents and two foreign patents which we have acquired, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure,confidentiality and other contractual restrictions to protect our proprietary technology. We also have patent applications currently pending and in the process ofbeing submitted. However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitiveadvantage. For example, some or all of our pending patent applications or any future pending applications may be unsuccessful. The U.S. Patent and TrademarkOffice may deny or require significant narrowing of claims in our pending patent applications or future patent applications, and patents issued as a result of thesepatent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. We could also incursubstantial costs in proceedings before the U.S. Patent and Trademark Office. These proceedings could result in adverse decisions as to the priority of ourinventions and the narrowing or invalidation of claims in our issued patents. Third parties may successfully challenge our issued patents and those that may beissued in the future, which would render these patents invalidated or unenforceable, and which could limit our ability to stop competitors from marketing and sellingrelated products. In addition, our pending patent applications include claims to aspects of our products and procedures that are not currently protected by issuedpatents, and third parties may successfully patent those aspects before us or otherwise challenge our rights to these aspects.Both the patent application process and the process of managing patent disputes can be time consuming and expensive. Competitors may be able to design aroundour patents or develop products that provide outcomes that are comparable to our products. Although we have entered into confidentiality agreements andintellectual property assignment agreements with certain of our employees, consultants and advisors in order to protect our intellectual property and otherproprietary technology, these agreements may not be enforceable or may not provide meaningful protection for trade secrets or other proprietary information in theevent of unauthorized use or disclosure or other breaches of the agreements. In addition, we have not sought patent protection in all countries where we sell ourproducts. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may useour technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing productsto territories in which we have patent protection that may not be sufficient to terminate infringing activities. Furthermore, the laws of some foreign countries may notprotect intellectual property rights to the same extent as the laws of the U.S., if at all.28In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents and rights may be difficult and timeconsuming. Even if successful, litigation to defend our patents against challenges or to enforce our intellectual property rights could be expensive and timeconsuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources to defend our patents againstchallenges or to enforce our intellectual property rights, any of which would adversely affect our ability to compete and our business operations as a result.If our trademarks or trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our businessmay be adversely affected.Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to infringe other marks. Wemay be unable to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in markets ofinterest. If our trademarks are challenged, infringed upon, circumvented, or declared generic or infringing, or if we are unable to establish name recognition based onour trademarks and trade names, then we may be unable to compete effectively and our business may be adversely affected.The medical device industry is characterized by extensive patent litigation, and if we become subject to litigation, it could be costly, result in the diversion ofmanagement’s attention, require us to pay significant damages or royalty payments, or prevent us from marketing and selling our existing or future products.The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Determiningwhether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Our competitors may assert that theirproducts, the components of those products, the methods of using those products, or the methods we employ in processing those products are covered by U.S. orforeign patents held by them. In addition, they may claim that their patents have priority over us because their patents were issued first. Because patent applicationscan take many years to issue, our products that currently do not infringe on existing issued patents may later infringe on patents that are pending now or in thefuture. Our products might also inadvertently infringe on currently issued patents. As the number of participants in the market for skin cancer and general oncologydevices and treatments increases, the possibility of patent infringement claims against us increases. Any infringement claims, litigation or other proceedings wouldplace a significant strain on our financial resources, divert the attention of management from the core business and harm our reputation.A larger more established company could allege that we infringed its patent, and that we owe royalty payments on sales of certain products as a result. Any claimagainst us, even without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention ofmanagement from the core business and harm our reputation. If the appropriate authority upholds the company’s patent as valid and enforceable and finds that weinfringed on the patent, we could be required to pay substantial damages, including treble, or triple, damages and royalties if an infringement is found to be willful,and we could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. A license may not beavailable on reasonable terms, if at all, and we may be unable to redesign products in a way that would not infringe those patents. If we fail to obtain any requiredlicenses or make any necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable tocommercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition and results of operations.Any potential intellectual property litigation also could force us to do one or more of the following:●stop selling, making, or using products that use the disputed intellectual property;●obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royaltypayments and may not be available on reasonable terms, or at all;29●incur significant legal expenses;●pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;●pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or●redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive or infeasible.Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.We may indemnify our customers and international distributors with respect to infringement by our products of the proprietary rights of third parties. Third partiesmay assert infringement claims against customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf ofcustomers or distributors, regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of customers ordistributors or may be required to obtain licenses for the products they use, each which would adversely affect our operations. If we cannot obtain all necessarylicenses on commercially reasonable terms, customers may be forced to stop using our products, which would materially and adversely affect our business.We may be subject to damages resulting from claims that we, our employees or independent distributors have wrongfully used or disclosed alleged trade secretsof competitors or are in breach of noncompetition or nonsolicitation agreements with our competitors.Many of our employees were previously employed at other medical device companies, including our competitors or potential competitors. Many of our independentdistributors sell, or in the past have sold, products of competitors. We may be subject to claims that we, our employees or independent distributors haveinadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the futurebe subject to claims that we caused an employee or independent distributor to break the terms of his or her noncompetition agreement or nonsolicitationagreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result insubstantial costs and be a distraction to management. If we fail in defending these claims, in addition to paying monetary damages, we may lose valuable intellectualproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have anadverse effect on our business, financial condition and results of operations.Adverse outcomes in litigation or similar proceedings could adversely impact our business.We may in the future be, named as a party to litigation or other similar legal proceedings. Adverse outcomes in any or all of these proceedings could result inmonetary damages or injunctive relief that could adversely affect our ability to continue conducting our business. If an unfavorable final outcome in any such matterbecomes probable and reasonably estimable, our financial condition could be materially and adversely affected.Risks Related to the Ownership of our SecuritiesLimited trading activity for shares of our common stock and warrants may contribute to price volatility.While our common stock and warrants are listed and traded on the Nasdaq Capital Market, there has been limited trading activity in our securities. Due to the limitedtrading activity of our securities, relativity small trades may have a significant impact on the price of our securities.30With two exceptions, we have never declared or paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. Asa result, you must rely on price appreciation of our common stock for a return on your investment in the foreseeable future. Except for a required tax distribution in 2014 in the aggregate amount of $45,421, and a onetime payment in the aggregate amount of approximately $2.6 million paidto former holders of our LLC units with a preferred return in 2016 (prior to our conversion to a corporation), we have never declared or paid cash dividends on ourcommon stock. We currently expect to retain our funds and future earnings to support the operation, growth and development of our business. We do not anticipatepaying any cash dividends on our common stock in the foreseeable future. As a result, a return on your investment in the near future will occur only if our shareprice appreciates. Our securities prices may not appreciate in value or maintain the prices at which you purchased our securities, and in either case, you may notrealize a return on investment or could lose all or part of your investment in our securities.Furthermore, any future determination to declare cash dividends will be made at the discretion of our board of directors and will be subject to compliance withapplicable laws and covenants under any future credit facilities, which may restrict or limit our ability to pay dividends. For example, our current revolving line ofcredit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior written consent ofthe lender, provided that we may pay dividends solely in common stock. Also, the form, frequency and amount of dividends will depend upon our future operationsand earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.We may not pay dividends as a result of any of the foregoing, and in these cases, you will need to rely on price appreciation of our common stock for a return onyour investment.General stock market volatility could result in significant declines in the trading price of our securities, and you could lose all or a substantial part of yourinvestment. Stock markets have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. These broad marketfluctuations may adversely affect the trading price of our securities. In addition, limited trading volume of our securities may contribute to its future volatility. Pricedeclines in our securities could result from general market and economic conditions, some of which are beyond our control, and a variety of other factors, includingany of the risk factors described in this Annual Report on Form 10K. These broad market and industry factors may harm the market price of our securities,regardless of our operating performance, and could cause you to lose all or part of your investment in our securities since you might be unable to sell your securitiesat or above the price you paid. Factors that could cause fluctuations in the market price of our securities include the following:●price and volume fluctuations in the overall stock market from time to time;●volatility in the market prices and trading volumes of medical device company stocks;●changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular;●sales of our securities by us or our stockholders;●failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or ourfailure to meet these estimates or the expectations of investors;●the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections;●rumors and market speculation involving us or other companies in our industry;●actual or anticipated changes in our results of operations or fluctuations in our results of operations;●actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;●litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors;●developments or disputes concerning our intellectual property or other proprietary rights;●announced or completed acquisitions of businesses or technologies by us or our competitors;●new laws or regulations or new interpretations of existing laws or regulations applicable to our business;●changes in accounting standards, policies, guidelines, interpretations or principles;●any significant change in our management; and●general economic conditions and slow or negative growth of our markets.In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigationhas often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’sattention and resources.31We are both an “emerging growth company” and a “smaller reporting company” and the reduced reporting requirements applicable to emerging growthcompanies and smaller reporting companies may make our common stock less attractive to investors. We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act. For as long as we continue to be an emerging growth company, wemay take advantage of exemptions from various reporting requirements that are applicable to other public companies but not to “emerging growth companies,”including, but not limited to:●being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, withcorrespondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;●not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404of the SarbanesOxley Act;●not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory auditfirm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;●reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and●exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachutepayments not previously approved.We will remain an emerging growth company until the earlier of (1) December 31, 2021, (2) the last day of the year in which (a) we have total annual gross revenue ofat least $1 billion, or (b) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by nonaffiliatesexceeds $700 million as of the prior June 30th, and (3) the date on which we have issued more than $1 billion in nonconvertible debt during the prior threeyearperiod. Investors may find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as aresult of any choices to reduce future disclosure, there may be a less active trading market for our common stock and the price of our common stock may be morevolatile.Under the Jumpstart Our Business Startups Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We are a “smaller reporting company,” meaning that our outstanding common stock held by nonaffiliates had a value of less than$250 million at the end of our mostrecently completed second fiscal quarter. Thus, even if we are no longer an emerging growth company, as a smaller reporting company, we could take advantage ofcertain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of ourinternal control over financial reporting. As aresult, investors and others may be less comfortable with the effectiveness of our internal controls and the risk thatmaterialweaknesses or other deficiencies in internal controls go undetected may increase. In addition, as a smaller reporting company, we takeadvantage of ourability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing onlytwo years of audited financialstatements in annual reports and simplified executive compensation disclosures. Consequently, it may be morechallenging for investors to analyze our results ofoperations and financial prospects, as the information we provide to stockholders may bedifferent from what one might receive from other public companies inwhich one holds shares.32Our executive officers, directors and principal stockholders may exert control over us and may exercise influence over matters subject to stockholder approval. Our executive officers and directors, together with their respective affiliates, beneficially owned approximately 33% of our outstanding common stock as of March 8,2019. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election ofdirectors and approval of corporate transactions, such as a merger. This concentration of ownership could have the effect of delaying or preventing a change incontrol or otherwise discourage a potential acquirer from attempting to obtain control over us, which in turn could have a material adverse effect on the market valueof our common stock.If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, the price of our securities andtrading volume could decline. The trading market for our securities will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. We maybe unable to attract or sustain coverage by wellregarded securities and industry analysts. If either none or only a limited number of securities or industry analystscover us or our business, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for oursecurities would be materially and negatively impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover usor our business downgrade our securities or publish inaccurate or unfavorable research about us or our business, the price of our securities would likely decline. Ifone or more of these analysts cease coverage of us or our business, or fail to publish reports on us or our business regularly, demand for our securities coulddecrease, which might cause the price of our securities and trading volume to decline.Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may preventattempts by our stockholders to replace or remove our current directors and management. Provisions of Delaware law (where we are incorporated), our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition thatstockholders may consider favorable, including transactions in which you might otherwise receive a premium for your stock. In addition, these provisions mayfrustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace or removeour board of directors. These provisions include:●authorizing the issuance of “blank check” preferred stock without any need for action by stockholders;●requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of our stock our assets;●eliminating the ability of stockholders to call and bring business before special meetings of stockholders;●prohibiting stockholder action by written consent;●establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on bystockholders at stockholder meetings;●dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and●providing that our directors may be removed only by the affirmative vote of at least 75% of our thenoutstanding common stock and only for cause.In addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an antitakeover effect with respect to transactions notapproved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares ofour common stock.These provisions will apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board ofdirectors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.33Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between usand our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers oremployees. Our certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware isthe exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claimagainst us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that isgoverned by the internal affairs doctrine. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage these lawsuits against us and our directors, officers and other employees. If acourt were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incuradditional costs associated with resolving the action in other jurisdictions, which could harm our business and financial condition.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’views of us or our business could be harmed, resulting in a decrease in value of our common stock. As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in our internal controls. In addition,we are required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the SarbanesOxleyAct. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reportingbeginning with our annual report on Form 10K following the date on which we are no longer an emerging growth company, which may be up to five full yearsfollowing the date of our IPO, or the date we no longer qualify as a smaller reporting company. Our compliance with Section 404 of the SarbanesOxley Act willrequire us to incur substantial accounting expense and expend significant management efforts. If we are unable to comply with the requirements of Section 404 in atimely manner, or we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to bematerial weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or otherregulatory authorities, which would require additional financial and management resources.Our ability to implement our business plan successfully and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. Weexpect that we will need to continue to improve existing, and implement new, operational and financial systems, procedures and controls to manage our businesseffectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause our operations tosuffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internal controls fromour auditors when required under Section 404 of the SarbanesOxley Act. Moreover, we may not implement and maintain adequate controls over our financialprocesses and reporting in the future. Even if we were to conclude, and, when required, our auditors were to concur, that our internal control over financial reportingprovided reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles, because of our inherent limitations, internal control over financial reporting may not prevent or detect fraud ormisstatements or omissions.Our operations may be impaired if our information technology systems fail to perform adequately or if we are the subject of a data breach or cyberattack.Our information technology systems are critically important to operating our business efficiently. We rely on our information technology systems to manage ourbusiness data, communications, employee information, and other business processes. We outsource certain business process functions to thirdparty providers andsimilarly rely on these third parties to maintain and store confidential information on their systems. The failure of these information technology systems to performas we anticipate could disrupt our business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing ourbusiness and results of operations to suffer.34Although we protect our information technology systems, we have experienced varying degrees of cyberincidents in the normal conduct of our business, includingviruses, worms, phishing and other malicious activities. Although there have been no serious consequences to date, such breaches could result in unauthorizedaccess to information including customer, supplier, employee, or other company confidential data. We do carry insurance against these risks, perform penetrationtests from time to time, and design our business processes to attempt to mitigate the risk of such breaches. However, our efforts to mitigate these risks may beunsuccessful for security breaches not to occur. Moreover, the development and maintenance of these measures requires continuous monitoring as technologieschange and efforts to overcome security measures evolve. We have experienced, and expect to continue to experience, cyber security threats and incidents, none ofwhich has been material to us to date. However, a successful breach or attack could have a material negative impact on our operations and subject us toconsequences such as direct costs associated with incident response.Item 1B.UNRESOLVED STAFF COMMENTSNone.Item 2.PROPERTIESOur corporate headquarters and principal office is located in Boca Raton, Florida. Our corporate headquarters and principal office occupies approximately 8,926square feet of leased space. The lease was last extended in January 2018 and will expire in September 2022. Our Israeli subsidiary entered into a twoyear lease foroffice space in September 2018. Both of our leases contain escalating rent clauses. Our rental expense in 2018 was approximately $229,000. We believe that ourcurrent facilities are suitable and adequate to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.Our main manufacturing function is physically located at our third party manufacturer’s facility in Oak Ridge, Tennessee.Item 3.LEGAL PROCEEDINGSWe are party to certain legal proceedings in the ordinary course of business. We assess, in conjunction with our legal counsel, the need to record a liability forlitigation and related contingencies.Item 4.MINE SAFETY DISCLOSURENot applicable. 35PART II.Item 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITYSECURITIESCommon Stock Market PricesOur common stock trades on the Nasdaq Capital Market under the symbol “SRTS.” We had a total of 44 stockholders of record as of March 8, 2019. The followingtable presents the range of high and low closing sales prices reported on the Nasdaq Capital Market.20182017FourthQuarterThirdQuarterSecondQuarterFirstQuarterFourthQuarterThirdQuarterSecondQuarterFirstQuarterCommon stockprice:High$8.72$8.38$7.71$5.97$6.00$6.01$4.65$5.24Low5.316.705.755.224.853.503.524.35Close7.418.387.265.845.164.984.524.39DividendsWe have never declared or paid any dividend on our common stock. We anticipate that for the foreseeable future all earnings will be retained for use in our businessand we do not expect to pay dividends to stockholders. Any future payment of cash dividends on our common stock will be dependent upon our financialcondition, results of operations, current and anticipated cash requirements, plans for expansion, as well as other factors that our Board of Directors deems relevant.Additionally, certain contractual agreements and provisions of Delaware law impose restrictions on our ability to pay dividends. For example, our current revolvingline of credit restricts our ability to pay dividends or make any distributions or payments or redeem, retire or purchase any capital stock without the prior writtenconsent of the lender, provided that we may pay dividends solely in common stock without prior consent. Additionally, Section 170(a) of the Delaware GeneralCorporation Law (“DGCL”) only permits dividends to be paid out of two legally available sources: (1) out of surplus, or (2) if there is no surplus, out of net profits forthe year in which the dividend is declared or the preceding year (socalled “nimble dividends”). However, dividends may not be declared out of net profits if “thecapital of the corporation, computed in accordance with sections 154 and 244 of the DGCL, shall have been diminished by depreciation in the value of its property, orby losses, or otherwise, to an amount less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having apreference upon the distribution of assets.” Contractual obligations and applicable law will restrict our ability to declare and pay dividends in the future.Unregistered Sales of SecuritiesThere were no unregistered sales of securities during the year ended December 31, 2018.Purchases of Equity Securities by the Registrant and Affiliated PurchasersNone. Item 6.SELECTED FINANCIAL DATANot applicable.Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSYou should read the following management’s discussion and analysis (“MD&A”) in conjunction with the information set forth within the financial statements andrelated notes included in this Annual Report on Form 10K. The following information should provide a better understanding of the major factors and trends thataffect our earnings performance and financial condition, and how our performance during 2018 compares with the prior year. Throughout this section, SensusHealthcare, Inc. is referred to as “Company,” “we,” “us,” or “our.”36CAUTION CONCERNING FORWARDLOOKING STATEMENTSThis Annual Report on Form 10K, including this MD&A section, contains “forwardlooking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forwardlooking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates andintentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. Thewords “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended toidentify forwardlooking statements.All forwardlooking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in ourforwardlooking statements. Please see the Introductory Note and Item 1A Risk Factors of this Annual Report for a discussion of factors that could cause our actualresults to differ materially from those in the forwardlooking statements.However, other factors besides those listed in Item 1A Risk Factors or discussed in this Annual Report also could adversely affect our results, and you should notconsider any such list of factors to be a complete set of all potential risks or uncertainties. Any forwardlooking statements made by us or on our behalf speak onlyas of the date they are made. We do not undertake to update any forwardlooking statement, except as required by applicable law.Components of our results of operationsWe manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment andresource allocation decisions and assesses operating performance.RevenueOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there wereno necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services. The amount ofrevenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, acontract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determinesare within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performanceobligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price;(iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performanceobligation. The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.37The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Cost of salesSince 2010, we have used a third party manufacturer for the production and manufacture of our main products, the SRT100 product line, in accordance with ourproduct specifications. Cost of sales consists primarily of direct material, direct labor, overhead, depreciation and amortization. A significant portion of our cost ofsales consists of costs paid to our third party manufacturer.Gross profitWe calculate gross profit as net revenue less cost of sales. Our gross profit has been and will continue to be affected by a variety of factors, including averageselling price, manufacturing costs, production volumes, product reliability and the implementation over time of costreduction strategies. Our gross profit mayfluctuate from quarter to quarter.Selling and marketingWe focus on two primary markets private dermatology practices and radiation oncologists in both private and hospital settings. We currently employ a multitiersales strategy in an attempt to optimize geographic coverage and focus on what we perceive to be our key markets. This multitier sales model uses a directsalesforce in the U.S. and international dealers and distributors.General and administrativeGeneral and administrative expense consists primarily of salaries, employee benefits, bonuses, and related costs for personnel who support our general operationssuch as executive management, finance, accounting and administrative functions, as well as legal and other professional fees, director and officer insurance andother public company expenses.Research and developmentResearch and development costs relate to products under development by us and quality and regulatory costs and are expensed as incurred.Other income (expense)Other income (expense) primarily consists of interest earned on cash balances and investments less interest payments made pursuant to our secured credit facilitywith Silicon Valley Bank. Our interest expense will fluctuate in future periods to the extent we incur additional, or pay down, indebtedness.Income taxesUntil December 31, 2015, we were organized as a limited liability corporation taxed as a passthrough entity and accordingly, we did not recognize a federal or stateincome tax provision. Beginning in 2016, as a result of our conversion to a Delaware corporation, we began recording a provision for income tax (benefit) expense,which consists of income taxes in jurisdictions in which we conduct business. We are taxed at the rates applicable within each jurisdiction in which we operate orgenerate revenue. The composite income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdiction in which profitsarise. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercisejudgment in determining our income tax provision, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets.Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuationallowance is established when it is more likely than not that the future realization of all or some of the deferred tax assets will not be achieved.38On December 22, 2017, the United States enacted new federal tax reform legislation, resulting in significant changes from the prior tax law. The new tax law reducedthe federal corporate income tax rate to 21% from 35%, effective January 1, 2018. Our federal income tax expense for periods beginning in 2018 was based on the newrate. The new tax law also permits immediate deduction of 100% of the costs of qualified property that have been incurred and the property placed in service duringthe period from September 27, 2017 to December 31, 2022. This provision will begin to phase out by 20% per year beginning January 1, 2023 and will be completelyphased out as of January 1, 2027.Our subsidiary in Israel is taxed on its taxable income. The current corporate tax rate in Israel is 23%.InflationInflation has not had a material impact on net sales, revenues or income from operations for our two most recent years as a result of historically low levels ofinflation.Results of OperationsFor the Years Ended December 31,20182017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761) $(3,710,514) Year ended December 31, 2018 compared to the year ended December 31, 2017Total revenue. Total revenue was $26,427,190 for the year ended December 31, 2018 compared to $20,587,827 for the year ended December 31, 2017, an increase of$5,839,363, or 28.4%. The growth in revenue was attributable to an increase in the volume of systems sold as well as a higher percentage of sales of the higherpricedSRT100 Vision product in the current year.Total cost of sales. Cost of sales was $9,516,302 for the year ended December 31, 2018 compared to $6,787,836 for the year ended December 31, 2017, an increase of$2,728,466, or 40.2%. The increase in cost was due to a greater number of systems sold during the year ended December 31, 2018 compared to the correspondingperiod in 2017.Gross profit. Gross profit was $16,910,888 for the year ended December 31, 2018 compared to $13,799,991 for the year ended December 31, 2017, an increase of$3,110,897 or 22.5%, for the reasons discussed above. Our overall gross profit margin was 64.0% in the year ended December 31, 2018 compared to 67.0% in thecorresponding period in 2017, mainly due to the mix of products sold during 2018.39Selling and marketing. Selling and marketing expense was $8,531,622 for the year ended December 31, 2018 compared to $8,305,315 for the year ended December 31,2017, an increase of $226,307 or 2.7%. The increase was primarily attributable to an increase in commission expense directly related to the increase in sales offset by areduction in marketing activities during 2018.General and administrative. General and administrative expense was $4,124,214 for the year ended December 31, 2018 compared to $3,721,627 for the year endedDecember 31, 2017, an increase of $402,587, or 10.8%. The net increase was due primarily to stock compensation expense of $444,000 from the grant of fully vestedshares to directors.Research and development. Research and development expense was $6,260,406 for the year ended December 31, 2018 compared to $5,490,489 for the year endedDecember 31, 2017, an increase of $769,917 or 14.0%. The increase in research and development spending was attributable to the acceleration of research projects in2018.Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our investment inheldtomaturity securities and cash equivalents. Other income, net increased in 2018 due to interest on the net proceeds received from the share offering inSeptember 2018.Financial ConditionOur cash, cash equivalent and investment balance increased to $15,376,446 at December 31, 2018 from $11,190,103 at December 31, 2017, primarily as a result of thenet public offering proceeds from our shelf take down in September 2018 of approximately $15.8 million, partially offset by the cash used in operations during 2018.Borrowings under the revolving line of credit were $0 as of December 31, 2018, compared to $2,214,970 at December 31, 2017. Outstanding borrowings under the lineof credit were repaid from the proceeds of the shelf takedown.Liquidity and Capital ResourcesOverviewIn general terms, liquidity is a measurement of our ability to meet our cash needs. For the years ended December 31, 2018 and 2017, a significant source of fundinghas been from cash flows from financing activities, including our public offering in 2018, as well as from borrowings under our revolving line of credit. We believethat proceeds from our public offerings, our borrowing capacity and our access to capital resources are sufficient to meet our anticipated operating capital andfunding requirements for the foreseeable future. Our liquidity position and capital requirements may be impacted by a number of factors, including the following:●our ability to generate and increase revenue;●fluctuations in gross margins, operating expenses and net results; and●fluctuations in working capital.Our primary shortterm capital needs, which are subject to change, include expenditures related to:●expansion of our sales and marketing activities; and●expansion of our research and development activities.We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect toraise additional funds for these purposes in the future.40Cash flowsThe following table provides a summary of our cash flows for the periods indicated:For the Years Ended December 31,20182017Net Cash Provided by (Used In):Operating Activities$(8,517,760)$(3,056,606)Investing Activities(2,688,360)6,173,913Financing Activities13,604,9081,925,684Increase In Cash and Cash Equivalents$2,398,788$5,042,991Cash flows from operating activitiesNet cash used in operating activities was $8,517,760 for the year ended December 31, 2018, consisting of a net loss of $2,022,761 and an increase in net operatingassets of $8,244,406, partially offset by noncash charges of $1,749,406. The increase in net operating assets was primarily due to the increase in sales and otherlonger payment terms on certain sales, resulting in an increase in accounts receivable, an increase in prepaid and other current assets and an increase in accountpayable and accrued expenses. Noncash charges consisted primarily of stock compensation expense and depreciation and amortization. Net cash used in operatingactivities was $3,056,606 for the year ended December 31, 2017, consisting of a net loss of $3,710,514 and an increase in net operating assets of $568,857, offset bynoncash charges of $1,222,765.Cash flows from investing activitiesNet cash used in investing activities was $2,688,360 due the purchase of debt securities heldtomaturity of $2,892,190 and $900,805 for acquisition of property andequipment offset by matured investments of $1,104,635 during the year ended December 31, 2018. Net cash provided in investing activities totaled $6,173,913 for theyear ended December 31, 2017, which consisted of matured investments of $6,461,507 less $287,594 for acquisition of property and equipment.Cash flows from financing activitiesNet cash provided by financing activities was $13,604,908 during the year ended December 31, 2018, mostly from the gross proceeds of $17,249,995 from the offeringof common stock and $90,867 from exercise of warrants, partially offset by $2,214,970 repayment of our revolving credit facility, offering costs of $1,402,336 and$118,648 in withholding tax on stock compensation. Net cash provided by financing activities was $1,925,684 during the year ended December 31, 2017 of which$2,214,970 was from borrowing under our line of credit, partially offset by $289,286 on withholding taxes paid on stock compensation.IndebtednessPlease see Note 4 to the financial statements.Contractual Obligations and CommitmentsIn July 2016, we renewed our lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the officespace being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, we signed amendmentsto further expand our leased office space. Our wholly owned Israeli subsidiary also entered into a twoyear lease for office space in September 2018. Future minimumlease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,00041OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194OffBalance Sheet ArrangementsWe did not have during the periods presented, and do not currently have, any offbalance sheet arrangements.Critical Accounting Policies and EstimatesOur discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withgenerally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial conditionand results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements includedin this Annual Report on Form 10K.JOBS ActWe qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may takeadvantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the SarbanesOxley Act, reduced disclosureobligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financialstatements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory“sayonpay” votes on executive compensation and stockholder advisory votes on golden parachute compensation. We have availed ourselves of the reducedreporting obligations and executive compensation disclosure in this Annual Report on Form 10K, and expect to continue to avail ourselves of the reduced reportingobligations available to emerging growth companies in future filings.In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies.However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on therelevant dates on which nonemerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of theextended transition period for complying with new or revised accounting standards is irrevocable.Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKNot applicable.42Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFINANCIAL STATEMENTS OF SENSUS HEALTHCARE, INC.CONTENTSReport of Independent Registered Public Accounting Firm44Financial StatementsBalance Sheets as of December 31, 2018 and 201745Statements of Operations for the years ended December 31, 2018 and 201746Statements of Stockholders’ Equity for the years ended December 31, 2018 and 201747Statements of Cash Flows for the years ended December 31, 2018 and 201748Notes to financial statements4943REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Shareholders and Board of Directors ofSensus Healthcare, Inc.Opinion on the Financial StatementsWe have audited the accompanying balance sheets of Sensus Healthcare, Inc. (the “Company”) as of December 31, 2018 and 2017, the related statements ofoperations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2018, and the related notes (collectively referred to asthe “financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2018, in conformity withaccounting principles generally accepted in the United States of America.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States ofAmerica. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financialreporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Marcum llpMarcum llpWe have served as the Company’s auditor since 2012.Fort Lauderdale, FLMarch 15, 2019 44SENSUS HEALTHCARE, INC.BALANCE SHEETSAs of December 31,20182017AssetsCurrent AssetsCash and cash equivalents$12,484,256$10,085,468Accounts receivable, net13,145,9344,958,255Inventories1,628,8171,171,383Investment in debt securities2,892,1901,104,635Prepaid and other current assets1,750,994566,972Total Current Assets31,902,19117,886,713Property and Equipment, Net891,029394,078Patent Rights, Net433,737530,123Deposits24,27224,272Total Assets$33,251,229$18,835,186Liabilities and Stockholders’ EquityCurrent LiabilitiesAccounts payable and accrued expenses$5,166,239$4,067,894Product warranties136,217146,722Deferred revenue, current portion722,025652,242Total Current Liabilities6,024,4814,866,858Revolving Credit Facility—2,214,970Deferred Revenue, Net of Current Portion766,73273,083Total Liabilities6,791,2137,154,911Commitments and ContingenciesStockholders’ EquityPreferred stock, 5,000,000 shares authorized and none issued and outstanding——Common stock, $0.01 par value – 50,000,000 authorized; 16,145,915 issued and 16,112,461 outstanding at December31, 2018; 13,522,168 issued and 13,488,714 outstanding at December 31, 2017161,459135,221Additional paidin capital39,957,90523,181,641Treasury stock, 33,454 shares at cost, at December 31, 2018 and 2017.(133,816)(133,816)Accumulated deficit(13,525,532)(11,502,771)Total Stockholders’ Equity26,460,01611,680,275Total Liabilities and Stockholders’ Equity$33,251,229$18,835,186See accompanying notes to the consolidated financial statements. 45SENSUS HEALTHCARE, INC.STATEMENTS OF OPERATIONSFor the Years Ended December 31, 2018 2017Revenues$26,427,190$20,587,827Cost of Sales9,516,3026,787,836Gross Profit16,910,88813,799,991Operating ExpensesSelling and marketing8,531,6228,305,315General and administrative4,124,2143,721,627Research and development6,260,4065,490,489Total Operating Expenses18,916,24217,517,431Loss From Operations(2,005,354)(3,717,440)Other Income (Expense)Interest income139,27875,807Interest expense(156,685)(68,881)Other Income (Expense), net(17,407)6,926Net Loss$(2,022,761)$(3,710,514)Net Loss per share – basic and diluted$(0.14)$(0.28)Weighted average number of shares used in computing net loss per share – basic and diluted14,115,75713,236,519See accompanying notes to the consolidated financial statements.46SENSUS HEALTHCARE, INC.STATEMENTS OF STOCKHOLDERS’ EQUITYFOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017Common StockAdditionalTreasury StockSharesAmountPaidInCapitalSharesAmountAccumulatedDeficitTotalDecember 31, 201613,546,171$135,461$22,930,975—$—$(7,792,257)$15,274,179Stock based compensation5,00050405,846———405,896Surrender of shares for taxwithholding on stockcompensation(29,003)(290)(155,180)(33,454)(133,816)—(289,286)Net loss—————(3,710,514)(3,710,514)December 31, 201713,522,168$135,221$23,181,641(33,454)$(133,816)$(11,502,771)$11,680,275Issuance of common stock for cash,net of offering cost2,563,76425,63815,822,021———15,847,659Stock based compensation50,000500982,124———982,624Surrender of shares for taxwithholding on stockcompensation(19,305)(193)(118,455)———(118,648)Exercise of warrants and options29,28829390,574———90,867Net loss—————(2,022,761)(2,022,761)December 31, 201816,145,915$161,459$39,957,905(33,454)$(133,816)$(13,525,532)$26,460,016See accompanying notes to the consolidated financial statements. 47SENSUS HEALTHCARE, INC.STATEMENTS OF CASH FLOWSFor the Years Ended December 31,20182017Cash Flows From Operating ActivitiesNet loss$(2,022,761)$(3,710,514)Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:Bad debt expense (recoveries)(13,280)191,391Depreciation and amortization658,255387,917Provision for product warranties121,807237,561Stock based compensation982,624405,896Decrease (increase) in:Accounts receivable(8,174,399)(2,051,011)Inventories(661,419)118,925Prepaid and other current assets(1,184,023)333,751Increase (decrease) in:Accounts payable and accrued expenses1,098,3441,305,522Deferred revenue763,432(144,724)Product warranties(132,311)(131,320)Total Adjustments(6,540,970)653,907Net Cash Used In Operating Activities(8,563,731)(3,056,606)Cash Flows from Investing ActivitiesAcquisition of property and equipment$(854,834)$(287,594)Investment in debt securities held to maturity(2,892,190)—Investments matured1,104,6356,461,507Net Cash Provided By (Used In) Investing Activities(2,642,389)6,173,913Cash Flows from Financing ActivitiesOffering of common stock17,249,995—Revolving credit facility, net(2,214,970)2,214,970Offering costs(1,402,336)—Withholding taxes on stock compensation(118,648)(289,286)Exercise of warrants90,867—Net Cash Provided By Financing Activities13,604,9081,925,684Net Increase in Cash and Cash Equivalents2,398,7885,042,991Cash and Cash Equivalents – Beginning10,085,4685,042,477Cash and Cash Equivalents – Ending$12,484,256$10,085,468Supplemental Disclosure of Cash Flow InformationInterest Paid$156,685$43,316Non Cash Investing and Financing ActivitiesTransfer of inventory to property and equipment$203,987$35,393See accompanying notes to the consolidated financial statements. 48SENSUS HEALTHCARE, INC.NOTES TO THE FINANCIAL STATEMENTSNOTE 1 — ORGANIZATIONAND SUMMARYOF SIGNIFICANT ACCOUNTING POLICIESDESCRIPTIONOFTHE BUSINESSSensus Healthcare, Inc. (the “Company”) is a manufacturer of superficial radiation therapy devices and has established a distribution and marketing network to sellthe devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Companycompleted a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Companyopened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.PRINCIPLESOFCONSOLIDATIONThe accompanying condensed consolidated financial statements include the financial statements of the Company and its whollyowned subsidiary in Israel. Allintercompany balances and transactions have been eliminated.USEOF ESTIMATESThe preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements andthe reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in thenear term include, revenue recognition, inventory reserves, receivable allowances, recoverability of long lived assets and estimation of the Company’s productwarranties. Actual results could differ from those estimates.REVENUE RECOGNITIONOn January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modifiedretrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historicalrevenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to acustomer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generallyupon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to beentitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. Todetermine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i)identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of beingdistinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v)recognizes revenue when, or as, the Company satisfies each performance obligation.The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of thedevices and the service contract are usually signed at the same time and in some instances a service contract is signed on a standalone basis. Revenue for servicecontracts is recognized over the service contract period on a straightline basis. The Company determined that in practice no significant discount is given on theservice contract when it is offered with the device purchase as compared to when it is sold on a standalone basis, by comparing the median selling price of theservice contract as standalone and the median selling price of the service contract when sold together with the device. The service level provided is identical whenthe service contract is purchased standalone or together with the device. There is no termination provision in the service contract nor any penalties in practice forcancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for asignificant discount when purchased with the device. The service portion of a sales contract or a standalone service contract is accounted for over the period oftime of the service contract only when the customer exercises the option by paying for the service contract.49Disaggregated revenue for the year ended December 31, 2018 and 2017 was as follows:For the Years Ended December 31,20182017Product Revenue$24,651,212$19,003,723Service Revenue1,775,9781,584,104Total Revenue$26,427,190$20,587,827The Company operates in a highlyregulated environment in which state regulatory approval is sometimes required prior to the customer being able to use theproduct, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval isobtained.Deferred revenue as of December 31, 2018 was as follows:ServiceProductTotal DeferredRevenueBalance, beginning of period$643,325$82,000$725,325Revenue recognized(1,344,588)(49,000)(1,393,588)Amounts invoiced2,157,020—2,157,020Balance, end of period$1,455,757$33,000$1,488,757Deferred revenue increased due to new service contracts during the year ended December 31, 2018.The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year orless. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31,2018 is as follows:YearService Revenue2019$674,0262020441,2702021325,893202214,568Total$1,455,757The Company provides warranties, generally for one year, in conjunction with the sale of its product. These warranties entitle the customer to repair, replacement, ormodification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time theCompany recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.Shipping and handling costs are expensed as incurred and are included in cost of sales.CONCENTRATIONOF CREDIT RISKFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents, accounts receivable andinvestments in debt securities.50SEGMENTAND GEOGRAPHICAL INFORMATIONThe Company’s revenue is generated primarily from customers in the United States, which represented approximately 96% and 97% of revenue for the years endedDecember 31, 2018 and 2017, respectively. A single customer in the U.S. accounted for approximately 71% and 59% of revenue for the years ended December 31, 2018and 2017, respectively, and 87% of the accounts receivable as of December 31, 2018 and 2017.FAIR VALUEOF FINANCIAL INSTRUMENTSCarrying amounts of cash equivalents, accounts receivable, accounts payable and revolving credit facility approximate fair value due to their relative shortmaturities.CASHAND CASH EQUIVALENTSThe Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are$250,000 for deposits. As of December 31, 2018 and 2017, the Company had approximately $11,726,000 and $9,952,000, respectively in excess of federally insuredlimits.For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchasedto be a cash equivalent.INVESTMENTSShortterm investments consist of investments which the Company expects to convert into cash within one year and longterm investments after one year. TheCompany classifies its investments in debt securities at the time of purchase as heldtomaturity and reevaluates such classification on a quarterly basis. Heldtomaturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plusaccrued interest and consist of the following:AmortizedCostGrossUnrealizedGainGrossUnrealizedLossFairValueShort Term:Corporate bonds$602,599$—$256$602,343United States Treasury bonds502,036—332501,704Total Short Term:1,104,635—5881,104,047Total Investments December 31, 2017$1,104,635$—$588$1,104,047Short Term:Corporate bonds$2,892,190$—$623$2,891,567Total Short Term:2,892,190—6232,891,567Total Investments December 31, 2018$2,892,190$—$623$2,891,567ACCOUNTS RECEIVABLEThe Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure tolosses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses andmaintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was approximately $0 and $16,000as of December 31, 2018 and 2017, respectively. Bad debt recoveries and expense for the years ended December 31, 2018 and 2017 was approximately $13,000 inrecoveries and $191,000 in expense, respectively.51INVENTORIESInventories consist of finished product and components and are stated at the lower of cost and net realizable value, determined using the firstinfirstout method.PROPERTYAND EQUIPMENTProperty and equipment are stated at cost. Depreciation on property and equipment is calculated on the straightline basis over the estimated useful life of eachasset. Maintenance and repairs are expensed as incurred; expenditures that enhance the value of property or extend their useful lives are capitalized. When assetsare sold or returned, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income.Inventory units designated for customer demonstrations, as part of the sales process, are reclassified to property and equipment and the depreciation is recorded toselling and marketing expense. The inventory used for demonstrations that was reclassified to property and equipment for the years ended December 31, 2018 and2017 was approximately $158,000 and $35,000, respectively.INTANGIBLE ASSETSIntangible assets are comprised of the Company’s patent rights and are amortized over the patents’ estimated useful life of approximately 13 years. As of December31, 2018, the remaining useful life was 54 months.LONGLIVED ASSETSThe Company evaluates its longlived assets, including intangible assets, for possible impairment whenever circumstances indicate that the carrying amount of theasset, or related group of assets, may not be recoverable from estimated future cash flows in accordance with accounting guidance. If circumstances suggest therecorded amounts cannot be recovered, based upon estimated future undiscounted cash flows, the carrying values of such assets are reduced to fair value. Noimpairment charges were recorded for longlived assets for the years ended December 31, 2018 and 2017.RESEARCHAND DEVELOPMENTResearch and development costs related to products under development by the Company and quality and regulatory costs and are expensed as incurred.EARNINGS PER SHAREBasic net income (loss) per share is calculated by dividing the net income (loss) by the weightedaverage number of common shares outstanding for the periodusing the treasury stock method for options and warrants. The diluted net income per share is computed by giving effect to all potential dilutive common shareequivalents outstanding for the period. In periods when the Company has incurred a net loss, options and warrants to purchase common shares are consideredcommon share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares excluded were computedunder the treasury stock method as follows:For the Years Ended December 31,20182017Stock options31,694—Restricted shares17,365—Warrants—4,076EQUITYBASED COMPENSATIONPursuant to relevant accounting guidance related to accounting for equitybased compensation, the Company is required to recognize all sharebased payments tononemployees and employees in the financial statements based on fair values on the grant date. The Company has accounted for issuance of shares, options, andwarrants in accordance with the guidance, which requires the recognition of expense, based on grantdate fair values, over the service period, generally periods overwhich the shares, options and warrants vest.52ADVERTISING COSTSAdvertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling and marketing expense in theaccompanying statements of operations amounted to approximately $1,462,000 and $1,684,000 for the years ended December 31, 2018 and 2017, respectively.OPERATING LEASESRent expense for operating leases which contain escalating rental clauses is recorded on a straightline basis over the lease term.RECENTLYISSUEDANDADOPTEDACCOUNTINGSTANDARDSIn May 2014, the FASB issued ASU 201409, Revenue from Contracts with Customers (Topic 606). ASU 201409 eliminated transaction and industryspecificrevenue recognition guidance under current GAAP and replaced it with a principle based approach for determining revenue recognition. ASU 201409 requires thatcompanies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also requires additional disclosure aboutthe nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgmentsand assets recognized from costs incurred to obtain or fulfill a contract. ASU 201409 is effective for reporting periods beginning after December 15, 2017. Entitiescan transition to the standard either retrospectively or as a cumulativeeffect adjustment as of the date of adoption. In April 2016, the FASB also issued ASU 201610, Identifying Performance Obligations and Licensing, implementation guidance on principal versus agent, identifying performance obligations, and licensing. ASU201610 is effective for reporting periods beginning after December 15, 2017. Entities can transition to the standard either retrospectively or as a cumulativeeffectadjustment as of the date of adoption. The Company adopted the new revenue recognition standard in the first quarter of 2018 using the full retrospective method.The Company’s revenues were not materially impacted as a result of applying ASC 606 for the year ended December 31, 2018, and there have not been significantchanges to the Company’s business processes, systems, or internal controls as a result of implementing the standard.In February 2016, the FASB issued ASU No. 201602, “Leases (Topic 842).” The guidance in ASU 201602 supersedes the lease recognition requirements in ASCTopic 840, Leases (FAS 13). The new standard establishes a rightofuse (ROU) model that requires a lessee to record a ROU asset and a lease liability on thebalance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expenserecognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscalyears, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered intoafter, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. We willadopt the updated accounting guidance in the first quarter of 2019, but prior periods will not be adjusted. The Company does not expect this standard will have amaterial impact on its consolidated financial statements.In May 2017, the FASB issued ASU 201709, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting. The amendments included inthis update provide guidance about which changes to the terms or conditions of a sharebased payment award require an entity to apply modification accounting.The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in this update are effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company adopted this standard in the first quarter of 2018 and itdid not have a material impact on its financial statements.53NOTE 2 — PROPERTYAND EQUIPMENTAs of December 31,Estimated Useful20182017LivesOperations and rental equipment$852,273$542,6393 yearsTradeshow and demo equipment784,244271,2753 yearsComputer equipment112,52194,2983 years1,749,038908,212Less accumulated depreciation(858,009)(514,134)Property and Equipment, Net$891,029$394,078Depreciation expense was approximately $562,000 and $291,000 for the years ended December 31, 2018 and 2017, respectively. Accumulated depreciation on assetdisposals was approximately $218,000 for the year ended December 31, 2018.NOTE 3 — PATENT RIGHTSAs of December 31,20182017Gross carrying amount$1,253,018$1,253,018Less accumulated amortization(819,281)(722,895)Patent Rights, Net$433,737$530,123Amortization expense was approximately $96,000 for the years ended December 31, 2018 and 2017. As of December 31, 2018, future remaining amortization expense isas follows:For the Year Ending December 31,2019$96,386202096,386202196,386202296,386202348,193Total$433,737NOTE 4 — REVOLVING CREDIT FACILITYOn March 12, 2013, the Company entered into a twoyear $3 million revolving credit facility. The credit facility was amended and extended effective March 12, 2015through May 12, 2017. The maximum borrowing was reduced to $1,500,000 and was limited by the Company’s eligible borrowing base of 80% of eligible accountsreceivable. On September 21, 2016, a second amendment to the credit facility extended the facility through September 21, 2017, increased the maximum borrowing to$2,000,000 and expanded the eligible accounts receivables to include certain international receivables. The Company was not in compliance in April and May 2017with one of its financial covenants. On June 27, 2017, the covenant defaults were waived and the agreement was amended to modify the financial covenantseffective June 2017. An amendment signed on September 15, 2017 extended the maturity date of the credit line through November 19, 2017. On October 31, 2017, theCompany amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amendedfacility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million nonformula sublimit. The borrowing base consists of80% of eligible accounts receivable, as defined in the agreement.54Interest, at Prime plus 0.75% (6.25% at December 31, 2018) and Prime plus 1.50% on nonformula borrowings (7.00% at December 31, 2018), is payable monthly, andthe outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additionalindebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictivecovenant, as defined in the agreement. The Company was in compliance with its financial covenants as of December 31, 2018 and December 31, 2017. There were noborrowings outstanding under the revolving credit facility at December 31, 2018 and approximately $2,215,000 was outstanding at December 31, 2017. The Companypays commitment fees of 0.25% per annum on the average unused portion of the line of credit.NOTE 5 — PRODUCT WARRANTIESChanges in product warranty liability were as follows for the year ended December 31, 2018:Balance, beginning of period$146,722Warranties accrued during the period121,807Payments on warranty claims(132,312)Balance, end of period$136,217NOTE 6 — COMMITMENTAND CONTINGENCIESOPERATING LEASE AGREEMENTSIn July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded theoffice space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Companysigned amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two year lease for office space starting in September2018. Future minimum lease payments as of December 31, 2018 are as follows:YearMinimum LeasePayment2019$249,0002020245,0002021231,0002022177,000Total$902,000Rental expense for year ended December 31, 2018 and 2017 was approximately $229,000 and $178,000, respectively.MANUFACTURING AGREEMENTIn July 2010, the Company entered into a threeyear contract manufacturing agreement with an unrelated third party for the production and manufacture of theCompany’s main product in accordance with the Company’s product specifications. The agreement renews for successive years unless either party notifies theother party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has theoption to terminate the agreement with 90 days written notice.Purchases from this manufacturer totaled approximately $4,185,000 and $3,838,000 for the years ended December 31, 2018 and 2017, respectively. As of December 31,2018 and 2017, approximately $1,041,000 and $829,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses inthe accompanying balance sheets.55LEGALCONTINGENCIESThe Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need torecord a liability for litigation and related contingencies.In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by aphysician who had treated patients with the Company’s SRT100. The Company received a Civil Investigative Demand from the Department seeking documents andwritten responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that itwas considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. TheCompany disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims forreimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether theCompany engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, theCompany believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated withthis matter.NOTE 7 — EMPLOYEE BENEFIT PLANSWe sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions inaccordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certainlimits. Expenses related to this plan totaled approximately $107,000 and $95,000 for the years ended December 31, 2018 and 2017, respectively.NOTE 8 — STOCKHOLDERS’ EQUITYThe Company has authorized 50,000,000 shares of common stock, of which 16,145,915 were issued and 16,112,461 outstanding at December 31, 2018; 13,522,168shares were issued and 13,488,714 outstanding as of December 31, 2017, respectively.STOCK ISSUANCESOn September 17, 2018, the Company completed a public offering of 2,205,882 shares of its common stock, par value $0.01 per share, at a public offering price of $6.80per share. On September 21, 2018 the Company issued an additional 330,882 shares of its common stock pursuant to the exercise in full of the underwriters’ optionreceived in connection with the public offering of its common stock. After giving effect to the full exercise of the option, Sensus sold an aggregate of 2,536,764shares of its common stock at a price of $6.80 per share with total gross proceeds of approximately $17.25 million, and net proceeds of $15.85 million after deductingunderwriting discounts and commissions and other offering expenses.WARRANTSIn April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to fiveyear warrants topurchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018,73,309 of the warrants were exercised, and 13,067 warrants expired.In June 2016, from the Company’s IPO, the investors received threeyear warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 pershare; the warrants are exercisable through June 8, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company mayredeem any and all of the outstanding warrants at a price equal to $0.01 per warrant.56In addition, the underwriter’s representatives for the IPO received fouryear warrants to purchase up to 138,000 units, consisting of one share of common stock andone warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 perunit.The following table summarizes the Company’s warrant activity:Number ofWarrantsWeightedAverageExercisePriceWeightedAverageRemainingContractualTerm (In Years)Outstanding – December 31, 20172,524,376$6.671.50Granted———Exercised(73,309)4.55—Expired(13,067)4.55—Outstanding – December 31, 20182,438,000$6.750.55Exercisable – December 31, 20182,438,000$6.750.55The intrinsic value of the common stock warrants was approximately $1,609,000 as of December 31, 2018, and $19,000 as of December 31, 2017.2016 AND 2017 EQUITYINCENTIVE PLANSThe Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number ofshares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregatemay be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum numberof shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stockdividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition,on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018,30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a fouryear vesting period and are being recognized as expense on a straightline basis over the vesting period of the awards.On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a fouryear vesting period were grantedto employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at$3.52 per option using the assumptions noted in the following table. All 229,334 stock options were unvested and had an intrinsic value of approximately $427,000 asof December 31, 2018.2018Expected volatility67.8%Riskfree interest rate2.5%Expected life6.25 yearsDividend yield0.0%57The accounting guidance requires the use of a valuation model to calculate the fair value of each stockbased award. The Company uses the BlackScholes model toestimate the fair value of stock options granted based on the following assumptions:Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on thehistorical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.RiskFree Interest Rate. The riskfree interest rate is based on the implied yield on U.S. Treasury zerocoupon issues with remaining terms equivalent to the expectedterm of our stockbased awards.Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant tothe estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplifiedmethod” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting termand original contractual term of the options.The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitureswas approximately $39,000 and $7,000 for the years ended December 31, 2018 and 2017, respectively.Unrecognized stock compensation expense was approximately $1,391,000 as of December 31, 2018, which will be recognized over the remaining vesting period.The following table summarizes the Company’s restricted stock activity:SharesWeighted AverageGrant Date FairValueUnvested balance at December 31, 2017237,000$5.24Granted30,0008.58Vested(68,166)5.24Forfeited(33,000)5.25Unvested balance at December 31, 2018165,834$5.84TREASURY STOCKThe Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in theaccompanying condensed balance sheet. As of December 31, 2018 and 2017, the Company had 33,454 treasury shares.NOTE 9 — INCOME TAXESThe income tax provision (benefit) consisted of the following:For The Years EndedDecember 31,20182017Current – federal——Current – state——Deferred – federal(707,725)(767,337)Deferred – international(40,038)—Deferred – state(246,766)(114,049)(994,529)(881,386)Change in valuation allowance994,529881,386Income tax provision (benefit)$—$—58For the years ended December 31, 2018 and December 31, 2017, the expected tax expense (benefit) based on the statutory rate is reconciled with the actual taxexpense (benefit) as follows:For The Years EndedDecember 31,20182017U.S. federal statutory rate(21.0)%(35.0)%State taxes, net of federal benefit(4.8)%(2.7)%Foreign rate differential(0.2)%—Permanent differences2.4%3.2%Change in tax rates(4.0)%14.4%Returntoprovision adjustments(2.2)%—Tax credits(19.3)%(2.1)%Other—(1.6)%Change in valuation allowance49.2%23.8%Income tax provision (benefit)0.0%0.0%As of December 31, 2018 and December 31, 2017, the Company’s net deferred tax asset consisted of the effects of temporary differences attributable to the following:December 31,20182017Net operating losses$1,458,744$793,864Stockbased compensation122,23968,730Depreciation and amortization(97,700)12,473Accrued expenses and reserves45,10677,532Tax credit546,592155,320Other, net42,88515,418Deferred tax asset, net2,117,8661,123,337Valuation allowance(2,117,866)(1,123,337)Deferred tax asset, net of valuation allowance——The Company has federal tax net operating loss carryforwards of approximately $5,216,000 as of December 31, 2018 and state net operating loss carryforwardsspread across various jurisdictions with a combined total of approximately $6,069,000 as of December 31, 2018. The net operating loss carryforwards generated priorto January 1, 2018, if not used to reduce taxable income in future periods, will begin to expire in 2029, for both federal and state tax purposes. The net operating losscarryforward generated after December 31, 2017 will never expire for federal purposes but can only reduce 80% of taxable income in future years. Additionally, theCompany also has tax credit carryforwards of approximately $547,000 as of December 31, 2018. These credit carryforwards, if not used in future periods, will begin toexpire in 2029.In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will berealized. The ultimate realization of deferred tax assets is dependent upon the future generation of taxable income during the periods in which those temporarydifferences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and taxing strategies inmaking this assessment. Based on this assessment, management has established a full valuation allowance against all of the net deferred tax assets for each period,since it is more likely than not that all of the deferred tax assets will not be realized. The valuation allowance for the years ended December 31, 2018 and 2017increased by approximately $995,000 and $881,000, respectively.Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financialstatements as of December 31, 2018 and 2017. The Company does not expect any significant changes in its unrecognized tax benefits within 12 months of thereporting date. The Company has U.S. federal and certain state tax returns subject to examination by tax authorities beginning with those filed for the year endedDecember 31, 2014. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrativeexpenses in the consolidated statements of operations.59On December 22, 2017, the United States enacted tax reform legislation known as the H.R.1, commonly referred to as the “Tax Cuts and Jobs Act” (the “Act”),resulting in significant modifications to existing law. The Company has completed the accounting for the effects of the Act as of December 31, 2017. Our financialstatements for the year ended December 31, 2017, reflect certain effects of the Act which includes a reduction in the corporate tax rate from 35% to 21%, as well asother changes. As a result of the changes to tax laws and tax rates under the Act, the Company incurred an incremental increase in income tax expense ofapproximately $562,000 during the year ended December 31, 2017, which consisted primarily of the remeasurement of deferred tax assets and liabilities from 35% to21%. This incremental amount was offset by a change to the Company’s valuation allowance resulting in no net effect.NOTE 10 — SUBSEQUENT EVENTSThe Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued forpotential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financialstatements.Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone.Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Control and ProceduresAs of December 31, 2018, the end of the period covered by this Annual Report on Form 10K, our management, including our Chief Executive Officer and ChiefFinancial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a15(e) under the Securities Exchange Act of 1934).Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that as of December 31, 2018, the end of the period covered bythis Annual Report on Form 10K, we maintained effective disclosure controls and procedures.Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a15(f) and 15d15(f) underthe Exchange Act. We have performed an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer andour Chief Financial Officer, of the effectiveness of our internal control over financial reporting. Our management used the updated Internal ControlIntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission to perform this evaluation. Based on that evaluation, ourmanagement, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was effective as ofDecember 31, 2018.As an emerging growth company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financialreporting.Changes in Internal Control Over Financial ReportingThere have been no changes in our internal control over financial reporting during our most recently completed quarter that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.60Item 9B.OTHER INFORMATIONNone.PART III.Item 10.DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 11.EXECUTIVE COMPENSATIONThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREOWNERS MATTERSOur 2016 and 2017 Equity Incentive Plans were each approved by our stockholders. The following table provides certain information regarding the Company’sequity compensation plans.Plan CategoryNumber of securities tobeissued upon exercise ofoutstanding options,warrants and rightsWeightedaverageexercisepriceof outstanding options, warrants and rightsNumber of securitiesremaining availablefor future issuance underequitycompensation plans(excludingsecurities reflected incolumn(a)(a)(b)(c)Equity Compensation Plans Approved by Securities Holders229,334$5.55278,473Equity Compensation Plans Not Approved by Securities Holders———Total229,334$5.55278,473The other information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this item will be set forth in the Proxy Statement for our 2019 Annual Meeting and is incorporated into this report by reference.61PART IVItem 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this report1.Financial StatementsThe Company’s Financial Statements included in Part II of this Annual Report on Form 10K are incorporated by reference into this Item 15.2.Financial Statement SchedulesOther schedules and exhibits are omitted because the required information either is not applicable or is shown in the financial statements or the notesthereto.3.Exhibits Required to be Filed by Item 601 of Regulation SKThe Exhibit Index beginning on page 63 of this Annual Report on Form 10K is incorporated by reference to this Item 15.Item 16.FORM 10K SUMMARYNone.62SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned thereunto duly authorized.SENSUS HEALTHCARE, INC.Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChief Executive Officer(Principal Executive Officer)Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and inthe capacities and on the dates indicated.NameTitleDate/s/ Joseph SardanoChief Executive Officer and ChairmanMarch 15, 2019Joseph Sardano(Principal Executive Officer)/s/ Arthur LevineChief Financial OfficerMarch 15, 2019Arthur Levine(Principal Financial and Accounting Officer)/s/ John HeinrichDirectorMarch 15, 2019John Heinrich/s/ William H. McCallDirectorMarch 15, 2019William H. McCall/s/ Samuel O’RearDirectorMarch 15, 2019Samuel O’Rear/s/ Anthony B. PetrelliDirectorMarch 15, 2019Anthony B. Petrelli63EXHIBIT INDEXExhibit No.Description2.1Agreement and Plan of Merger, dated as of December 12, 2011, by and between Sensus Healthcare, LLC and Sensus Healthcare, LLC – incorporatedby reference to Exhibit 2.1 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).2.2Plan of Conversion of Sensus Healthcare, LLC – incorporated by reference to Exhibit 2.2 of the Company’s Registration Statement on Form S1 (filed2/10/16)(No. 333209451).3.1Amended and Restated Certificate of Incorporation of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.1 to the Company’sAmendment No. 2 to Registration Statement on Form S1 (filed 3/25/16)(No. 333209451).3.2Bylaws of Sensus Healthcare, Inc. – incorporated by reference to Exhibit 3.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).4.1Form of Representatives’ Warrant to Purchase Units– incorporated by reference to Exhibit 4.7 of the Company’s Amendment No. 4 to RegistrationStatement on Form S1 (filed 5/19/16) (No. 333209451).4.2Form of Indenture – incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S3 (filed 11/6/17)(No. 333221371).4.3Form of Warrant Agreement, by and between Sensus Healthcare, Inc. and American Stock Transfer & Trust Company, LLC, as warrant agent,including warrant certificate – incorporated by reference to Amendment No. 3 to the Company’s Registration Statement on Form S1/A (filed 5/13/16)(No. 333209451).10.1Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and Silicon Valley Bank, dated as of March 12, 2013 –incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).6410.2Default Waiver and First Amendment to Amended and Restated Loan and Security Agreement by and between Sensus Healthcare, LLC and SiliconValley Bank, dated May 12, 2015 – incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No.333209451).10.3Second Amendment and Restated Loan and Security Agreement by and between Sensus Healthcare, Inc. and Silicon Valley Bank, dated September21, 2016 – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.4Office Lease Agreement, dated as of July 26, 2010, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.6 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.5Amendment to Lease, dated as of January 27, 2014, by and between Rexall Sundown, Inc. and Sensus Healthcare, LLC– incorporated by reference toExhibit 10.7 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.6Commercial Lease, dated as of July 7, 2016, by and between BREF 851, LLC and Sensus Healthcare, Inc. – incorporated by reference to Exhibit 10.2 ofthe Company’s Quarterly Report on Form 10Q (filed 11/7/16)(No. 00137714).10.7+Sensus Healthcare, Inc. 2016 Equity Incentive Plan – incorporated by reference to Exhibit 10.14 of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).10.8+Form of NonQualified Option Grant Agreement – incorporated by reference to Exhibit 10.8 of the Company’s Registration Statement on Form S1(filed 2/10/16)(No. 333209451).10.9+Equity Grant Agreement, dated as of July 30, 2015, by and among Arthur Levine, Sensus Healthcare, LLC and certain contributing members namedtherein – incorporated by reference to Exhibit 10.9 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.10+Employment Agreement between Sensus Healthcare, Inc. and Joseph C. Sardano – incorporated by reference to Exhibit 10.10 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.11+Employment Agreement between Sensus Healthcare, Inc. and Kalman Fishman – incorporated by reference to Exhibit 10.11 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.12+Employment Agreement between Sensus Healthcare, Inc. and Arthur Levine – incorporated by reference to Exhibit 10.12 of the Company’sRegistration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.13#Manufacturing Agreement, dated as of July 20, 2010, by and between RbM Services, LLC and Sensus Healthcare, LLC – incorporated by reference toExhibit 10.13 of the Company’s Registration Statement on Form S1 (filed 2/10/16)(No. 333209451).10.14+Amendment to Equity Grant Agreement, dated as of November 16, 2016, by and among Arthur Levine, Sensus Healthcare, LLC and certaincontributing members named therein.10.15Sensus Healthcare, Inc. 2017 Equity Incentive Plan – incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8K (filed6/9/17)(No. 00137714).10.16Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on From10Q (filed 8/4/17)(No. 00137714).6510.17Second Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.18Third Amendment to Second Amended and Restated Loan and Security Agreement – incorporated by reference to Exhibit 10.2 of the Company’sQuarterly Report on From 10Q (filed 11/6/17)(No. 00137714).10.19+Form of Restricted Stock Award Agreement incorporated by reference to Exhibit 10.2 of the Company’s Registration Statement on Form S8 (filed11/6/17)(No. 333221372).10.20+Employment Agreement between Sensus Healthcare, Inc. and Michael Sardano – incorporated by reference to Exhibit 10.1 of the Company’sQuarterly Report on Form 10Q (filed 5/8/18) (No. 333209451).14.1Sensus Healthcare, Inc. Code of Ethics – incorporated by reference to Exhibit 14.1 of the of the Company’s Amendment No. 1 to RegistrationStatement on Form S1 (filed 3/10/16)(No. 333209451).21.1Subsidiaries – Incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10K (filed 3/10/17)(No. 00137714).23.1*Consent of Registered Independent Accounting Firm.31.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the SecuritiesExchange Act of 1934.31.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a14(a) of the Securities Exchange Act of 1934.32.1*Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.32.2*Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.101.INS*XBRL Instance Document101.SCH*XBRL Taxonomy Extension Schema Document101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document101.LAB*XBRL Taxonomy Extension Label Linkbase Document101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document101.DEF*XBRL Taxonomy Extension Definition Linkbase Document+Indicates a management contract or compensatory plan.#Portions of exhibit have been granted confidential treatment by the SEC.*Filed electronically herewith.66EX23.1 2 s116712_ex231.htm EXHIBIT 23.1Exhibit 23.1INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENTWe consent to the incorporation by reference in the Registration Statement of Sensus Healthcare, Inc. on Form S3 FILE NO. 333221371 of our report dated March15, 2019, with respect to our audits of the consolidated financial statements of Sensus Healthcare, Inc. as of December 31, 2018 and 2017 and for the years endedDecember 31, 2018 and 2017, which report is included in this Annual Report on Form 10K of Sensus Healthcare, Inc. for the year ended December 31, 2018./s/ Marcum LLPMarcum LLPFort Lauderdale, FLMarch 15, 2019EX31.1 3 s116712_ex311.htm EXHIBIT 31.1Exhibit 31.1Certification of CEO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Joseph C. Sardano, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. Date: March 15, 2019/s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive Officer1EX31.2 4 s116712_ex312.htm EXHIBIT 31.2Exhibit 31.2Certification of CFO Pursuant to Securities Exchange ActRule 13a14(a)/15d14(a) as Adopted Pursuant toSection 302 of the SarbanesOxley Act of 2002I, Arthur Levine, certify that:1.I have reviewed this annual report on Form 10K of Sensus Healthcare, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a15(e) and 15d15(e)) for the registrant and have:a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared;b.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andc.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, tothe registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 15, 2019/s/ Arthur LevineArthur LevineChief Financial Officer2EX32.1 5 s116712_ex321.htm EXHIBIT 32.1Exhibit 32.1Certification of CEO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Joseph C. SardanoJoseph C. SardanoChairman and Chief Executive OfficerMarch 15, 20193EX32.2 6 s116712_ex322.htm EXHIBIT 32.2Exhibit 32.2Certification of CFO Pursuant to 18 U.S.C. Section 1350Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the SarbanesOxley Act of 2002, the undersigned certificates that:(1) this Annual Report for Sensus Healthcare, Inc. (the “Company”) on Form 10K for the period ended December 31, 2018, as filed with the Securities and ExchangeCommission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for theperiods covered therein.A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature thatappears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request./s/ Arthur LevineArthur LevineChief Financial OfficerMarch 15, 20194

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