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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For the fiscal year ended December 31, 2023
OR
☐ 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: 001-39130
TELA Bio, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
1 Great Valley Parkway, Suite 24
Malvern, Pennsylvania
(Address of principal executive offices)
45-5320061
(I.R.S. Employer
Identification Number)
19355
(Zip Code)
Securities registered pursuant to Section 12(b) of the Act:
(484) 320-2930
(Registrant’s telephone number, including area code)
Title of each class:
Common Stock, $0.001 par value per share
Trading Symbol
TELA
Name of each exchange on which registered:
The Nasdaq Global Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known 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 the preceding 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 the past 90 days. ⌧ Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to
submit such files). ⌧ Yes☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and
“emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐
Non-accelerated filer ⌧
Accelerated filer ☐
Smaller reporting company ⌧
Emerging growth 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 revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its
internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the registered public accounting firm that
prepared or issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based
compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ⌧
As of June 30, 2023 (the last business day of the registrant’s most recently completed second fiscal quarter), the aggregate market value of the
registrant’s common stock held by non-affiliates was approximately $245.3 million based on the closing price of the common stock as reported on the
NASDAQ Global Market on June 30, 2023.
As of March 14, 2024, the registrant had 24,649,595 shares of Common Stock, $0.001 par value per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the definitive proxy statement to be filed with the U.S. Securities and Exchange Commission (the “SEC”) for TELA Bio’s 2024
annual meeting of stockholders are incorporated by reference into Part III of this Form 10-K
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Item No.
ITEM 1.
ITEM 1A.
ITEM 1B.
ITEM 1C.
ITEM 2.
ITEM 3.
ITEM 4.
ITEM 5.
ITEM 6.
ITEM 7.
ITEM 7A.
ITEM 8.
ITEM 9.
ITEM 9A.
ITEM 9B.
ITEM 9C.
ITEM 10.
ITEM 11.
ITEM 12.
ITEM 13.
ITEM 14.
TABLE OF CONTENTS
PART I
Page No.
BUSINESS
RISK FACTORS
UNRESOLVED STAFF COMMENTS
CYBERSECURITY
PROPERTIES
LEGAL PROCEEDINGS
MINE SAFETY DISCLOSURES
PART II
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
[RESERVED]
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
CONTROLS AND PROCEDURES
OTHER INFORMATION
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
PART III
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
EXECUTIVE COMPENSATION
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
PRINCIPAL ACCOUNTANT FEES AND SERVICES
ITEM 15.
ITEM 16.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
FORM 10-K SUMMARY
PART IV
EXHIBIT INDEX
SIGNATURES
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Annual Report”) and the documents incorporated by reference herein contain
“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, we
may, through our officers and other authorized representatives, make certain forward-looking statements in publicly
released materials, both written and oral, including statements contained in filings with the Securities and Exchange
Commission, press releases, and our communications with our stockholders.
Forward-looking statements are neither statements of historical facts nor assurances of future performance, but instead
discuss the future of our business, operations, future financial performance, future financial condition, plans, anticipated
growth strategies, anticipated or perceived trends in our business, the industry in which we operate or the broader economy,
and other objectives of management. In some cases, you can identify forward-looking statements by terminology such as
“aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,”
“goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,”
“would,” the negative of such terms, and other similar expressions although not all forward-looking statements contain
these identifying words.
You should understand that the following important factors could affect our future results and could cause those results or
other outcomes to differ materially from those expressed or implied in our forward-looking statements:
● estimates regarding future results of operations, financial position, research and development costs, capital
requirements and our needs for additional financing;
● the commercial success and degree of market acceptance of our products;
● the introduction of new products or product enhancements by us or others in our industry, including new products
which may be perceived to negatively impact the demand for our products now or in the future;
● our ability to expand, manage and maintain our direct sales and marketing organization and to market and sell our
products in the U.S. and Europe;
● the performance of our exclusive contract manufacturer for our OviTex and OviTex PRS products, Aroa
Biosurgery Ltd. (“Aroa”), in connection with the supply of product and in the development of additional products
and product configurations within these product lines;
● our ability to maintain our supply chain integrity and expand our supply chain to manage increased demand for
our products;
● our ability to compete successfully with larger competitors in our highly competitive industry;
● our ability to achieve and maintain adequate levels of coverage or reimbursement for our current products and
any future products we may seek to commercialize;
● our ability to enhance our products, expand our indications and develop and commercialize additional products;
● the development, regulatory approval, efficacy and commercialization of competing products;
● our business model and strategic plans for our products, technologies and business, including our implementation
thereof;
● the size of the markets for our current and future products;
● our ability to recruit and retain senior management and other highly qualified personnel;
● our ability to obtain additional capital to finance our planned operations;
● our ability to maintain regulatory approval for our products;
● our ability to commercialize or obtain regulatory approvals for our future products, or the effect of delays in
commercializing or obtaining regulatory approvals;
● decreasing selling prices and pricing pressures;
● regulatory developments in the U.S. and European markets;
● the potential impact of healthcare reform in the U.S., including the Inflation Reduction Act of 2022, and measures
being taken worldwide designed to reduce healthcare costs;
● the possible effects arising from pandemics, epidemics or outbreaks of a contagious illness, including coronavirus
disease, influenza, or respiratory syncytial virus among others and associated economic disruptions, including the
frequency of surgical procedures using our products, labor and hospital staffing shortages, supply
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chain integrity, and adverse healthcare economic factors affecting our products or the procedures in which they
are used;
● the volatility of capital markets and other adverse macroeconomic factors, including due to inflationary pressures,
interest rate and currency rate fluctuations, economic slowdown or recession, banking instability, geopolitical
tensions or the outbreak of hostilities or war, including from the ongoing Russia-Ukraine conflict and the current
conflict in Israel and Gaza (including any escalation or expansion);
● our ability to develop and maintain our corporate infrastructure, including our internal controls;
● our ability to establish and maintain intellectual property protection for our products, as well as our ability to
operate our business without infringing the intellectual property rights of others;
● our expectations regarding the use of proceeds from recent and any future financings, if any;
● the occurrence of adverse safety events, restrictions on use with our products or product liability claims; and
● other risks and uncertainties, including those listed under the caption “Risk Factors.”
These forward-looking statements are based on management's current expectations, estimates, forecasts and projections
about our business and the industry in which we operate, and management's beliefs and assumptions are not guarantees of
future performance or development and involve known and unknown risks, uncertainties and other factors that are in some
cases beyond our control. In light of the significant uncertainties in these forward-looking statements, you should not rely
upon forward-looking statements as predictions of future events. Although we believe the expectations reflected in the
forward-looking statements are reasonable, the future results, levels of activity, performance or events and circumstances
reflected in the forward-looking statements may not be achieved or occur at all.
You should refer to the section titled “Risk Factors” in this Annual Report for a discussion of important factors that may
cause our actual results to differ materially from those expressed or implied by our forward-looking statements.
Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required
by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new
information, future events or otherwise.
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SUMMARY RISK FACTORS
We are providing the following summary of the risk factors contained in our Form 10-K to enhance the readability
and accessibility of our risk factor disclosures. Additional discussion of the risks and uncertainties summarized in
this risk factor summary, as well as other risks and uncertainties that we face, can be found under “Cautionary
Note Regarding Forward-Looking Statements” and “Risk Factors” in this Annual Report. The below summary is
qualified in its entirety by those more complete discussions of such risks and uncertainties.
Risks Related to Achieving or Sustaining Profitability, Financial Position and Capital Requirements
● We have incurred significant operating losses since inception, we expect to incur operating losses in the future,
and we may not be able to achieve or sustain profitability.
● Our indebtedness may limit our flexibility in operating our business and adversely affect our financial health and
competitive position.
● We may require substantial additional capital to finance our planned operations, which may not be available to us
on acceptable terms or at all.
● If we are unable to expand, manage and maintain our direct sales and marketing organizations, we may not be
able to generate anticipated revenue.
● Macroeconomic conditions, including the lingering economic effects of the COVID-19 pandemic on hospital
systems may negatively impact certain aspects of our business, our prospects, results of operations and financial
condition.
● Rising inflation rates could negatively impact our revenues and profitability if increases in the prices of our
product or a decrease in consumer spending results in lower volumes of elective surgeries. In addition, if our costs
increase and we are not able to pass along these price increases, our profitability would be adversely affected, and
the adverse impact may be material.
Risks Related to the Commercialization of our Products
● To date, the vast majority of our revenue has been generated from sales of our OviTex products, and we therefore
are highly dependent on the commercial success of our OviTex product line.
● The commercial success of our products will largely depend upon attaining significant market acceptance.
● Even if we are able to attain significant market acceptance of our products, the commercial success of our
products is not guaranteed.
● The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that
lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are
deemed to have engaged in the promotion of our products for these uses.
● If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our OviTex, OviTex
PRS or other products we may commercialize in the future, our commercial success may be hindered.
● Our long-term growth may depend on our ability to enhance our product offerings.
● In the future our products may become obsolete, which would negatively affect operations and financial
condition.
● To successfully market and sell our products in markets outside of the U.S., we must address many international
business risks with which we have limited experience.
Risks Related to Our Reliance on Third Parties
● We are highly dependent upon Aroa as the exclusive contract manufacturer of our OviTex and OviTex PRS
products.
● We, or our partners, may experience development or manufacturing problems, capacity constraints, or delays in
the production of our products that could limit the potential growth of our revenue or increase our losses.
● Our products contain materials derived from animal sources and may become subject to additional regulation.
● Our supply of ovine rumen for use in manufacturing our products may be vulnerable to disruption due to natural
disaster, disease or other events.
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Risks Related to Intellectual Property Matters
● We may need to license intellectual property from third parties, and such licenses may not be available or may not
be available on commercially reasonable terms.
● If we fail to comply with our obligations under any license, collaboration or other agreements, we could lose
intellectual property rights that are necessary for developing and protecting our products.
● If we are unable to adequately protect our intellectual property rights, or if we are accused of infringing on the
intellectual property rights of others, our competitive position could be harmed, or we could be required to incur
significant expenses to enforce or defend our rights.
● Litigation or other proceedings or third-party claims of intellectual property infringement could require us to
spend significant time and money, enter into license agreements for disputed intellectual property and could
prevent us from selling our products.
● If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be
harmed.
Risks Related to Government Regulation
● Our products and operations are subject to extensive government regulation and oversight both in the U.S. and
internationally.
● We may not receive, or may be significantly delayed in receiving, the necessary clearances or approvals for our
future products and modifications to our current products may require new 510(k) clearances or premarket
approval, and may require us to cease marketing or recall the modified products until clearances or approvals are
obtained.
● Although we have obtained regulatory clearance for our products, they will remain subject to extensive regulatory
scrutiny.
● If guidelines for soft-tissue reconstruction surgery change or the standard of care evolves, we may need to
redesign and seek new marketing authorization from the U.S. Food and Drug Administration for our OviTex and
OviTex PRS products or other products we may commercialize in the future.
Risks Related to Our Business and Products
● Our financial results may fluctuate significantly and may not fully reflect the underlying performance of our
business.
● We may be unable to renew existing or obtain additional contract positions with major group purchasing
organizations and integrated delivery networks for our products, and even if we are able to do so, such contracts
may not generate sufficient sales of our products.
● We have limited data and experience regarding the safety and efficacy of certain of our products. Results of
earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such
products.
● Interim or preliminary data from our clinical trials that we announce or publish from time to time may change as
more patient data become available and are subject to audit and verification procedures that could result in
material changes in the final data.
Risks Related to Our Securities
● The trading price of the shares of our common stock has been and could in the future be highly volatile.
● Our directors, officers and principal stockholders have significant voting power and may take actions that may
not be in the best interests of our other stockholders.
● We are an emerging growth company and the reduced disclosure requirements applicable to emerging growth
companies may make our common stock less attractive to investors.
● Provisions in our corporate charter documents and under Delaware law could discourage another company from
acquiring us and may prevent attempts by our stockholders to replace or remove our current management.
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ITEM 1.
BUSINESS
Overview
PART I
We are a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction
solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy. Our
growing product portfolio is purposefully designed to leverage the patient’s natural healing response while minimizing
long-term exposure to permanent synthetic materials. We are committed to delivering our advanced technologies with a
strong economic value proposition to assist surgeons and institutions in providing next-generation soft-tissue repair
solutions to more patients worldwide.
We are dedicated to building true partnerships with surgeons and healthcare providers to deliver solutions that provide both
clinical and economic improvements. We believe that genuine collaboration with surgeons and healthcare providers results
in the development of new solutions that empower patient care.
Our first portfolio of products, the OviTex Reinforced Tissue Matrix (“OviTex”), which we first commercialized in the
U.S. in July 2016 and in Europe in February 2019, addresses unmet needs in hernia repair and abdominal wall
reconstruction by combining the benefits of biologic matrices and polymer materials while minimizing their shortcomings,
at a cost-effective price.
Hernia repair is one of the most common surgeries performed in the U.S., representing approximately 1.1 million
procedures annually. Based on the volume weighted average selling price of our OviTex products, we estimate the annual
U.S. total addressable market opportunity for our OviTex products to be approximately $1.5 billion.
Our OviTex portfolio consists of multiple product configurations intended to address various surgical procedures within
hernia repair and abdominal wall reconstruction, including ventral, inguinal, and hiatal hernia repair. In addition, we have
also designed an OviTex product specifically for use in laparoscopic and robotic-assisted hernia repair, which we market as
OviTex LPR and we began commercializing this product in November 2018. In February 2023, we launched two new,
larger configurations of OviTex LPR, designed for ventral and incisional hernias. More recently, we have designed a set of
OviTex products specifically for use in the inguinal hernia repair (“IHR”), which we expect to launch in the second quarter
of 2024.
We have also focused on evaluating and publishing clinical data on the effectiveness and safety of our OviTex products. To
date, there have been over thirty published or presented works relating to these clinical findings, either by us or a third-
party evaluating the OviTex product. In October 2022, the 24-month results of our single arm, multicenter post-market
clinical study, which we refer to as our BRAVO study, were published in the Annals of Medicine and Surgery. The BRAVO
study was designed to evaluate the clinical performance of OviTex for primary or recurrent ventral hernias using open,
laparoscopic, or robotic techniques in 92 enrolled patients. The recurrence rate at the 24-month time point was 2.6%, and
surgical site occurrences (“SSOs”) were observed in 38% of the study population. Of the enrolled patients, 78% were
characterized as high risk for experiencing an SSO based on at least one known risk factor, which included obesity, active
smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years). The results also indicated that
BRAVO patients experienced statistically significant and clinically meaningful improvements in their quality of life and
perceived health based on patient responses to the EuroQol-5 Dimension (EQ-5D) health assessment and the validated 12-
question Hernia-Related Quality of Life survey (HerQLes). In addition to the BRAVO study and other current clinical
initiatives, we also commenced enrollment in May 2021 for our BRAVO II study, a prospective study evaluating the use of
OviTex in robot-assisted ventral and inguinal hernia repairs.
Our second portfolio of products, the OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), which we first
commercialized in the U.S. in May 2019, addresses unmet needs in plastic and reconstructive surgery. OviTex PRS is
indicated for use in implantation to reinforce soft-tissue where weakness exists in patients requiring soft-tissue repair or
reinforcement in plastic and reconstructive surgery. Our OviTex PRS portfolio consists of three product configurations with
two or three layers of high-quality tissue derived from ovine rumen (the forestomach of a sheep), which is
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reinforced with either permanent or resorbable polymer for added strength, stabilization, and controlled stretch. These
products are designed to improve outcomes by facilitating functional tissue remodeling while controlling the degree and
direction of stretch. In August 2023, we announced the launch of our OviTex PRS Long-Term Resorbable product
configuration, which was designed to enhance the OviTex PRS portfolio with specific design features including bi-
directional stretch and a fully resorbable, long-term polymer for reinforcement.
Our OviTex PRS portfolio is supported by non-human primate data that demonstrated more rapid tissue integration and
tissue remodeling compared to the market leading biologic matrix used in this indication. Based on the current sales of
biologic matrices in the U.S., we estimate the annual U.S. current addressable market opportunity for our OviTex PRS
products to be approximately $700 million.
Our OviTex products have received 510(k) clearances from the U.S. Food and Drug Administration (“FDA”), which
clearances were obtained and are currently held by our exclusive contract manufacturer of these products, Aroa. In April
2019, our first OviTex PRS products received 510(k) clearance from the FDA, which clearance was initially obtained by
Aroa and is currently held by us. In March 2023, we received an additional 510(k) clearance for our OviTex PRS Long-
Term Resorbable device, which is currently held by us. We have also engaged in discussions with the FDA regarding an
Investigational Device Exemption (“IDE”) protocol to study the safety and effectiveness of our OviTex PRS product for an
indication in breast reconstruction surgery. The FDA has stated that a premarket approval (“PMA”), rather than 510(k)
clearance will be required for such an indication. We have also commenced a retrospective clinical study evaluating the
effectiveness and safety of our OviTex PRS products.
We also continue to expand our service offerings and diversify our supplier base as we continue to create a soft tissue
preservation and restoration portfolio, including through the development of complimentary solutions in our indications
such as atraumatic mesh fixation devices or surgical wound management and infection control. In September 2023, we
entered into a distribution agreement with Advanced Medical Solutions Limited, a company registered in England, to be
their exclusive distributor of their LiquiFix Hernia Mesh Fixation Devices (LiquiFix FIX8™ and LiquiFix Precision™). In
March 2024, we announced the full commercial launch of LiquiFix in the U.S. We previously co-developed and
commercialized our NIVIS Fibrillar Collagen Pack (“NIVIS”), an absorbent matrix of Type I and Type III bovine collagen
designed to manage moderately to heavily exudating wounds and to control minor bleeding, in partnership with Regenity
Biosciences. In March 2024, we sold our distribution rights to MiMedx Group, Inc. in exchange for an initial $5.0 million
payment and additional future payments aggregating between a minimum of $3.0 million and a maximum of $7.0 million
based on net sales of NIVIS over the next two years. We continue to assess additional strategic partnerships with medical
device companies whereby we may enter into distribution, product development and/or licensing agreements for new
products complimentary to, or related to, existing and future products in our distribution channel.
We have a broad portfolio of intellectual property protecting our products that we believe, when combined with the
proprietary manufacturing processes associated with our products and our know-how, provides significant barriers to entry.
Our intellectual property applies to our differentiated product construction and materials. In addition, we believe our
exclusive manufacturing and long-term supply and license agreement (the “Aroa License”) with Aroa creates a competitive
advantage by allowing us to secure an exclusive supply of ovine rumen at a low cost. Ovine rumen is the source of the
biologic material used in our OviTex and OviTex PRS products. We use biologic material from ovine rumen because of its
plentiful supply, optimal biomechanical profile and open collagen architecture that allows for rapid cellular infiltration. Our
OviTex products are manufactured by Aroa at their FDA registered and ISO 13485 compliant facility in Auckland, New
Zealand. We purchase product from Aroa at a fixed transfer cost as a percentage of Aroa’s cost of goods sold, and, with the
exception of our recent IHR-dedicated products equals 27% of our net sales of licensed products. This revenue sharing
arrangement allows us to competitively price our products and pass along cost-savings to our customers.
We market our products through a single direct sales force, predominantly in the U.S., as augmented by a smaller number
of sales representatives and distributors in certain European countries. We have invested in our direct sales and marketing
infrastructure to expand our presence and to promote awareness and adoption of our products. As of December 31, 2023,
we had 91 sales territories in the U.S. As part of our commercial strategy, we plan to continue to invest in our commercial
organization by hiring additional territory managers and administrative and field-based support
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employees to support and service new accounts for soft-tissue reconstruction procedures. We believe we can enhance the
productivity of our sales force by improving customer segmentation and targeting, implementing and further refining our
proprietary training programs, leveraging support from our medical education and medical affairs functions to drive
physician awareness, education and clinical understanding of our products, and utilizing engagement analytics to support
further product development and enhancement opportunities. Additionally, we have contracted with three national group
purchasing organizations (“GPOs”) covering our OviTex and OviTex PRS products and plan to continue to contract with
additional GPOs and other integrated delivery networks (“IDNs”) to increase access to and penetration of hospital
accounts.
We are currently devoting research and development resources to develop additional variations of our OviTex and OviTex
PRS product lines, including the additional IHR configurations to further enhance product compatibility in robotic
procedures, larger versions of our current product configurations, the development of configurations with longer-acting
resorbable polymers and other potential product and packaging enhancements to extend the shelf life of our products. In
addition, we also continue to explore the development of lower-cost, higher-margin resorbable polymer-based devices
targeting our current indications. We are also exploring additional technologies that may complement our existing products,
or expand the number of our product lines, in each case within the hernia, plastic and reconstruction, and broader soft-
tissue reconstruction and preservation markets. We intend to continue to make investments in research and development
efforts to develop improvements and enhancements to our product portfolio. We are also assessing strategic partnerships
with medical device companies whereby we may enter into distribution, product development and/or licensing agreements
for products complimentary to, or related to, existing and future products in our distribution channel, which could result in
the payment by us of single digit percentage royalties or other product acquisition costs.
Our business was directly impacted by the COVID-19 pandemic. We experienced volatility in demand for our products
which primarily resulted from government and hospital restrictions, as well as patient health and safety concerns,
decreasing the volume of elective procedures using our products. While procedure volumes have continued to normalize to
pre-pandemic levels, we continue to monitor any lingering economic effects on labor and hospital staffing levels,
procedural volumes and ultimately on our results.
Our revenue for the years ended December 31, 2023 and 2022 was $58.5 million and $41.4 million, respectively, which
represents an increase of $17.0 million, or 41% for the year ended December 31, 2023. Our net loss for the same time
periods was $46.7 million and $44.3 million, respectively, which represents an increase of $2.4 million, or 5% for the year
ended December 31, 2023. As of December 31, 2023, we had an accumulated deficit of $320.9 million. The vast majority
of our revenue to date has been generated from sales of our OviTex and OviTex PRS products in the U.S., with the
remainder generated from sales of our OviTex products in Europe and the sale of other products.
Market Opportunity
OviTex
Hernia repair is one of the most common surgeries performed in the U.S. There are an estimated 1.1 million hernia repairs
annually in the U.S. including recurrences, which we categorize as approximately (i) 60,000 complex/moderate ventral
hernia repairs and abdominal wall reconstructions, (ii) 345,000 simple ventral hernia repairs and (iii) 665,000 inguinal
hernia repairs, and (iv) 40,000 hiatal hernia repairs.
The healthcare burden of hernia disease to patients, insurers and employers is significant. For the patient, a hernia may
cause an increasing level of pain when lifting, straining during urination or a bowel movement, or sitting or standing for
long periods of time. Increased pain from the hernia is the most common reason that a patient who is deferring surgical
hernia repair will ultimately elect repair surgery. Following surgical hernia repair, convalescence has a significant
socioeconomic impact. Absence from work during this period can range from approximately five to 14 days according to
one study. Pain is the most common cause of delay in returning to work, followed by wound problems. Long-term pain or
discomfort at the hernia repair site is one of the most serious complications of hernia surgery and may, in some cases,
persist for years.
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Given the limitations of and lack of innovation in existing hernia repair products, we believe a significant market
opportunity exists for our portfolio of OviTex products. Based on the volume weighted average selling price of our OviTex
products, we estimate the annual U.S. total addressable market opportunity for our OviTex products to be approximately
$1.5 billion.
Approximate
Number of
Annual
U.S. Hernia
Procedures
Using
Tissue
Reinforcement
Material
60,000
345,000
665,000
40,000
1,110,000
Complex/Moderate Ventral Repair /Abdominal
Wall Reconstruction
Simple Ventral Hernia Repair
Inguinal Hernia Repair
Hiatal Hernia Repair
Total
OviTex PRS
Estimated
Annual
U.S. Total
Addressable
Market
Opportunity
$
Traditional
Products
Utilized
360 million Biologic Matrices and Resorbable
Synthetic Mesh
515 million Permanent Synthetic Mesh
600 million Permanent Synthetic Mesh
40 million Biologic Matrices and Resorbable
Synthetic Mesh
1.5 billion
$
$
$
$
Modern advances in tissue engineering have transformed the plastic and reconstructive surgeon’s management strategies
across a wide variety of applications. Because biologic matrices incorporate into host tissues and enable revascularization
and functional tissue remodeling, surgeons have realized multiple applications for their use, with techniques tailored to the
specific requirements of the surgery. There is growing clinical literature validating the use of biologic matrices in head and
neck surgery and reconstructions of the chest wall, pelvic region, extremities and breast.
In head and neck surgery, biologic matrices are used for both aesthetic and reconstructive purposes that include: surgery of
the nose to change its shape or improve its function, referred to as rhinoplasty; lip augmentation; repair of perforations of
the cartilage and thin bone separating the nostrils referred to as the nasal septum; complex reconstruction of the oral and
oropharynx cavities after oncologic resection; cleft palate repair; upper and lower eyelid reconstruction; scalp defects and
defects of the fibrous membrane covering the brain and spinal cord referred to as dura. In chest wall reconstruction,
biologic matrices are used to repair defects from oncologic resections. In pelvic reconstruction, biologic matrices are
utilized as an adjunct in the reconstruction of acquired pelvic defects caused by resections for colorectal, gynecologic and
urologic malignancies. In extremities reconstruction, biologic matrices are used in the upper extremity for repair of the
donor site following the harvest of a radial forearm free flap, a procedure used to harvest tissue and replace it in the head
and neck after cancer has been resected. In breast reconstruction, biologic matrices are utilized for prosthetic based
reconstruction following the removal of cancerous breast tissue.
Based on the current sales of biologic matrices in the U.S., we estimate the annual U.S. current addressable market
opportunity for our OviTex PRS products to be approximately $700 million. Given the limitations of and lack of
innovation in existing biologic matrices for plastic and reconstructive surgical procedures, we believe a significant market
opportunity exists for our OviTex PRS portfolio products.
Current Materials Used in Hernia Repair and Abdominal Wall Reconstruction and Their Limitations
Hernia Repair and Abdominal Wall Reconstruction
The vast majority of hernias are treated with surgical repair. Surgical hernia repair is performed either through open repair,
which uses a single incision to open the abdomen or groin across the hernia, or minimally invasive repair, which involves
laparoscopic or robotic-assisted techniques. Laparoscopic surgery is a minimally invasive surgical technique performed in
the abdomen or groin through small incisions. Surgical instruments and devices, such as mesh products, are then delivered
to the surgical site through a trocar, which is an access port to the patient’s abdomen or groin. Robotic-
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assisted surgery is also performed using small incisions in the patient’s abdomen or groin and a trocar, but the surgeon sits
at a console in the operating room and operates the robotic instruments remotely.
At the advent of hernia repair, all procedures were performed using an open surgical technique in which an incision is
made through the body to access and repair the hernia. Due to the amount of healthy soft-tissue disruption required for an
open procedure, there is a high risk of wound-related complications and seroma formation. In the early 1990s, surgeons
began using a laparoscopic approach for hernia repair because it provided the benefits of lower wound complication rates,
lower patient morbidity and decreased length of stay for patients. Despite these benefits, laparoscopic surgery presents
surgeons with challenges, primarily due to restricted instrument dexterity that makes it difficult to achieve primary closure
of the hernia defect, in which the connective tissue layer is sutured closed, and leads to a bridged repair. In a bridged repair,
the tissue reinforcement material spans a portion of the hernia defect without any connective tissue layer above it to
provide additional reinforcement. This leads to increased risk of bulging of the material or hernia recurrence. Robotic-
assisted hernia repair addresses this issue while still providing the benefits of a laparoscopic repair. In robotic-assisted
repair, the surgeon enjoys greater instrument dexterity and precision, and is able to achieve primary closure of the hernia
defect. This has contributed to a significant increase in the number of robotic-assisted hernia repairs over the last
several years.
It is estimated that about 90% of hernia repairs today use a form of reconstruction material to provide long-term support at
the repair site. Reconstruction materials include synthetic mesh, which can be either permanent or resorbable, and biologic
matrices made from tissue material.
In October 2020, we surveyed a group of 71 surgeons to better understand their receptivity to natural repair solutions, their
technique preferences across their hernia practice and their views on the risks associated with plastic mesh. Feedback was
gathered across inguinal hernia, simple ventral, moderate-to-complex ventral and hiatal hernia repair. Included in the group
were 43 general surgeons (61%), 19 plastic reconstructive surgeons (27%) and the remainder were colorectal and trauma
surgeons. These surgeons indicated they believe there is a role for natural repair products across all hernia segments and
they expect to increase their usage of those products in the next 24 months. Almost 60% of surgeons stated that they are
aware of the risks associated with plastic mesh and reported approximately 20% of their hernia patients have voiced
concern about the use of plastic mesh within the past 12 months.
In May 2023, we commissioned a consumer survey of 1,152 consumers on consumer awareness, preferences and doctor
expectations regarding hernia repair options. The results of this survey indicated a preference for more natural hernia repair
options (57%), particularly among those who have previously had a repair using permanent synthetic mesh (77%). The
majority of respondents also expressed a reliance on primary care physicians and healthcare professionals for guidance,
emphasizing the importance of shared decision-making.
Permanent Synthetic Mesh
Permanent synthetic mesh, the oldest category of hernia repair materials, is made of plastic materials that are also used in
industrial and consumer products. These products have gained popularity with surgeons because they are relatively inert,
can be readily sterilized, exhibit biomechanical strength and durability and are available at relatively low upfront cost.
Limitations of permanent synthetic mesh products may include:
● significant persistent foreign body inflammatory response that can result in encapsulation of the implant by
fibrotic tissue or contraction of the mesh;
● chronic post-operative pain;
● scar tissue formation and lack of regeneration of soft-tissue;
● permanent susceptibility to mesh infection;
● significant cost associated with subsequent repairs or failed and infected mesh;
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● compromised abdominal wall anatomy due to damaged and eroded tissue rendering subsequent surgical
repairs challenging; and
● migration of the permanent synthetic mesh which can result in organ erosion or perforation.
Many of these complications caused by permanent synthetic mesh require additional surgical intervention, including,
explantation of the mesh or repair of hernia recurrence or of the abdominal wall. Based on longitudinal data from the
Danish Hernia Database, in an analysis of approximately 2,900 patients who received a hernia repair using a permanent
synthetic mesh, the observed rate of surgical intervention due to either recurrence or mesh-related complications at
five years post operatively was approximately 17%. As a result of these complications and litigation involving these
complications, the number of adverse events reported to the FDA for permanent synthetic mesh hernia repairs has risen
from 1,484 in 2016, 3,220 in 2017, 9,887 in 2018 to 18,072 in 2019. Synthetic mesh products have been the subject of an
increasing number of lawsuits with over 25,000 cases filed in federal and state courts across the U.S. as of March 2024.
Biologic Matrices
The complications associated with permanent synthetic mesh prompted the development of biologic matrices as a second
category of hernia repair materials. Biologic matrices are derived from human or animal dermis, pericardium or intestinal
submucosa, which allows them to become replaced entirely by the patient’s own tissue over time, a process known as
remodeling. The goal behind these biologic materials was to lower the foreign body inflammatory response and
biomechanical requirements of the repair, while providing a matrix upon which tissue remodeling could occur. Compared
to permanent synthetic mesh, biologic matrices are less likely to induce this inflammatory response and become infected;
however, they may have the following limitations:
● lack strength or durability as compared to synthetic mesh products;
● prone to laxity and stretching;
● difficult to handle, leading to longer operating times as compared to synthetic mesh products;
● inability to be placed in a patient through a trocar in laparoscopic or robotic-assisted surgery; and
● considerably more expensive upfront costs than permanent synthetic mesh, typically limiting their use to
complex hernia repairs or abdominal wall reconstructions.
Though hernia recurrence occurs with the use of all types of soft-tissue reconstruction, biologic matrices have the highest
rates of recurrence, partly due to common use in complex hernia repairs or abdominal wall reconstructions. The RICH
study, a multicenter, prospective study sponsored by LifeCell Corporation (“LifeCell”) that evaluated the performance of
Strattice, the industry leader for biological tissue matrices in complex abdominal wall reconstruction, in open ventral
incisional hernia repair in contaminated abdominal wall defects, demonstrated post-operative hernia recurrence rates of
19% and 28% at 12-months and 24-months follow-up, respectively.
Resorbable Synthetic Mesh
Resorbable synthetic mesh, including biologically-derived synthetic mesh, was introduced as a third category of hernia
repair materials and as an alternative to permanent synthetic mesh and biologic matrices. Resorbable synthetic mesh was
designed with the intended benefits of full degradation over several months, a moderately lower cost than biologic matrices
and gradual transfer of strength from synthetic mesh to native tissue over time. Resorbable synthetic mesh is polymer-
based and does not include biologic material to promote tissue remodeling and healing. Despite improvements
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compared to the use of permanent synthetic mesh or biologic matrices, current limitations of resorbable synthetic mesh
may include:
● significant foreign body inflammatory response that can result in encapsulation or contraction of the mesh
until resorbed;
● scar tissue formation and lack of remodeling of soft-tissue;
● mesh infection until resorbed;
● migration of the mesh until resorbed which can result in organ erosion or perforation; and
● lack of mid-term and long-term soft-tissue reinforcement as resorption progresses.
Many of these complications can require additional surgical intervention including explantation of the resorbable synthetic
mesh or repair of hernia recurrence or the abdominal wall. Data from a published, multicenter, prospective study sponsored
by C.R. Bard, Inc. (now a subsidiary of Becton, Dickinson and Company) that evaluated the performance of Phasix, the
current market-leading resorbable synthetic mesh, in CDC Class I, high risk ventral and incisional hernia repair, showed a
post-operative hernia recurrence rate of 9% at 18-months follow-up and 18% at 36-month follow-up.
Current Materials Used in Plastic and Reconstructive Surgery and Their Limitations
Biologic matrices are most commonly used in plastic and reconstructive surgery, including surgery of the nose to change its
shape or improve its function, referred to as rhinoplasty, lip augmentation, repair of perforations of cartilage and thin bone
separating the nostrils, complex reconstruction of the oral and oropharynx cavities after oncologic resection, cleft palate
repair, upper and lower eyelid reconstruction, scalp defects, and defects of the fibrous membrane covering the brain and
spinal cord, called the dura, because of their ability to define shape and position, improve tissue quality, reinforce existing
soft-tissue and reduce the rate of complications associated with a foreign body inflammatory response, however they are
prone to excessive stretching over time and difficult for surgeons to handle. These limitations may lead to undesirable
results requiring additional surgical intervention. Additionally, biologic matrices are typically expensive to source.
Our Solution
We have created a new category of tissue reinforcement materials that were purposefully designed in close collaboration
with more than 100 surgeons to address the unmet clinical needs in soft-tissue reconstruction. Our portfolio of products,
generally designed with over 95% biologic material, combines the benefits of both biologic and polymer materials while
addressing their limitations by interweaving polymer fibers through layers of a minimally-processed biologic material.
These products are priced competitively and designed for use with a range of surgical techniques, allowing the benefits of
an advanced biologic repair to be available to more patients for use in accordance with the products’ 510(k) clearances and
instructions for use.
The biologic material serves as the natural building block from which we can fabricate devices that meet specific clinical
and surgical handling requirements. This material consists of an intact, minimally-processed extracellular matrix derived
from ovine rumen, which is the forestomach of a sheep. Polymer fibers are interwoven through the layers of biologic
material in unique embroidered patterns and contribute to approximately 5% of the overall device by mass. The interwoven
polymer utilized can be either permanent, made from polypropylene, or resorbable, made from polyglycolic acid (“PGA”)
or polylactic-co-glycolic acid (“PLGA”). The embroidering pattern varies between our OviTex and OviTex PRS portfolios
to impart different biomechanical properties tailored for their respective intended clinical applications. Our OviTex
products are designed with a lockstitch embroidery pattern that is sewn in a grid pattern to minimize unraveling (when cut).
Our OviTex PRS products are designed with a patented corner-lock stitch pattern designed to resist deformation and to
control the degree and direction of stretching of the product.
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Our capabilities in polymer science, biologics, textile engineering and analytical testing enable us to quickly design
innovative products for development and manufacture. These competencies also allow our technical team to tailor the
degree of stretch, direction of stretch, overall strength, handling properties, permeability, thickness, texture, size and shape
of each reinforced tissue matrix to suit the needs of particular clinical applications and surgical techniques. This expertise
has been utilized in the development of our OviTex and OviTex PRS products and is currently being leveraged in the
development of our additional OviTex and OviTex PRS product pipeline seeking to enhance product features for various
applications within our indications.
Our reinforced tissue matrices are designed to improve the outcomes of soft-tissue reconstructions by reinforcing tissue
while allowing rapid tissue integration, revascularization and biomechanical control. In addition to overall strength, a key
property that we engineer into our products is the degree to which they stretch, known as compliance. Each of our products
is designed to exhibit a degree of compliance appropriate for its intended clinical application.
The graphics below illustrate the key features of our OviTex and OviTex PRS products:
OviTex
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OviTex PRS
We believe the principal benefits of our reinforced tissue matrices are:
● Reduced foreign body inflammatory response. The biologic material utilized in our reinforced tissue
matrices is designed to minimize the body’s inflammatory response to the device. Our unique embroidered
patterns create a macroporous grid within the biologic material. In our non-human primate study in which we
compared our OviTex products to several commercially available synthetic mesh and biologic matrix
products, at 24 weeks, our OviTex products demonstrated a minimal foreign body inflammatory response
similar to that of biologic matrices, and less foreign body inflammatory response than all of the synthetic
mesh tested.
● Enhanced remodeling of soft-tissue and rate of healing. Our reinforced tissue matrices are constructed to
provide increased surface area and permeability, allowing for rapid absorption of wound fluids and blood
during implantation and enabling oxygen supply, cellular infiltration, migration, and repopulation for
revascularization and functional tissue remodeling during healing. In our non-human primate comparative
study, at 24 weeks the pattern of collagen formation in our OviTex products resembled connective tissue as
opposed to the random fibers typical of scar tissue that were seen adjacent to the synthetic mesh. By contrast,
the synthetic mesh showed no signs of remodeling of soft-tissue and exhibited a high level of mesh
contraction.
● Highly engineered biomechanical properties supported by clinical evidence. Our reinforced tissue matrices
are reinforced with interwoven polymer fibers to provide mid-term and long-term support. The interwoven
polymer increases the strength of our OviTex products by approximately 25% compared to the biologic
material alone. When tensile forces are applied, this design allows for load sharing between the biologic
material and the polymer during the remodeling process. Data from our strength testing demonstrated that
our OviTex products meet or exceed that of published data from market-leading permanent and resorbable
synthetic mesh. In our BRAVO study, the recurrence rate at the 24-month time point was 2.6%, and SSOs
were observed in 38% of the study population. Of the enrolled patients, 78%
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were characterized as high risk for experiencing an SSO based on at least one known risk factor, which
included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75
years). Based on this data, we believe that this recurrence rate is the lowest reported rate in any published
study, including our biologic or resorbable synthetic mesh competitors. The addition of polymer to our
reinforced tissue matrices allows each product to maintain its physiologic compliance properties, while
resisting stretching and elongation. In our non-human primate comparative study, our OviTex devices best
preserved their original shape, experiencing less contraction compared to biologic and synthetic mesh.
● Enhanced surgeon handling and satisfaction. Each of our embroidery patterns was designed specifically to
allow the surgeon to trim and shape the product while minimizing the potential for unraveling of the polymer.
Based upon our survey of approximately 50 surgeons, our OviTex products conform readily to the contours
of surgical sites and are easy to handle, trim, suture and tack in all surgical approaches. In addition, in our
BRAVO study, 32 of the 92 enrolled subjects received minimally invasive surgery, of whom 12 received
laparoscopic repair and 20 received robotic repair. Of the surgeons who performed minimally invasive
surgery, all reported at the time of surgery that the product was easy or very easy to place. The average
surgeon satisfaction with the product was 9.7/10 at 30 days for the minimally invasive cohort and remained
consistent over 24 months of follow-up. We are also actively enrolling patients in our BRAVO II study, a
prospective study evaluating robot-assisted ventral and inguinal hernia repairs with OviTex, including our
OviTex LPR, OviTex Core Permanent and OviTex 1S Permanent configurations.
● Lower upfront cost products. Our reinforced tissue matrices provide our customers with meaningful cost
savings over leading competitive products across a range of clinical uses so that more patients can experience
the benefits of an advanced biologic repair solution. We price our OviTex products competitively, and on
average, our customers realize 20% to 40% cost savings over leading biologic matrices and resorbable
synthetic mesh. Our OviTex PRS portfolio is priced below leading biologic matrices.
Our Strengths
We are focused on developing and commercializing a new category of tissue reinforcement materials for surgeons and
patients that aim to address the shortcomings of existing products. We believe the following strengths will allow us to build
our business and potentially increase our market penetration:
● Innovative and broad portfolio of products. Our OviTex and OviTex PRS products are the only FDA-
cleared products to incorporate polymer fibers interwoven through layers of biologic material in a lockstitch
pattern creating an embroidered construction. The biologic matrix is derived from ovine rumen and utilizes a
patented process to create a reinforced tissue matrix that is optimized for soft-tissue reconstruction. Our
OviTex and OviTex PRS products are available in resorbable and permanent polymer versions in a variety of
configurations and sizes. For example, our OviTex devices are currently available in sizes ranging from 4 × 8
cm to 25 × 40 cm, and our OviTex LPR devices are designed with specific thickness, handling properties and
shapes optimized for use in laparoscopic and robotic-assisted surgery.
● Disruptive technology supported by compelling pre-clinical and clinical evidence. OviTex product
technology is supported by extensive pre-clinical research, including bench testing, in-vitro and in-vivo
studies. These studies have demonstrated appropriate physiologic strength for the repair, compliance within
the physiologic range of the human abdominal wall, retention of extracellular matrix proteins which may aid
in tissue remodeling and porosity and permeability to promote fluid transfer. Our in-vivo non-human primate
data demonstrated that use of our OviTex products resulted in more rapid tissue integration and
revascularization compared to pure biologic matrices, as well as lower inflammatory response and better
functional tissue remodeling compared to permanent and resorbable synthetic mesh. This preclinical data is
supported by our compelling clinical evidence showing the safety and efficacy of our OviTex products in
published data on over 1,000 hernia patients.
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● Long-term supply agreement that provides pricing flexibility. Our Aroa License provides for the exclusive
supply of ovine rumen and manufacture of our OviTex and OviTex PRS products, which gives us a low and
fixed cost of raw materials. We purchase product from Aroa at a fixed transfer cost as a percentage of Aroa’s
cost of goods sold, and, with the exception of our recent IHR-dedicated products equals 27% of our net sales
of licensed products.
● Potential cost savings to healthcare systems and hospitals. Our pricing flexibility allows us to sell our
OviTex and OviTex PRS products to hospitals and healthcare systems at prices substantially below
competitive products based on national average competitive pricing. Our OviTex products are sold at prices
approximately 20% to 40% lower than other biologic matrices and resorbable synthetic mesh. We believe our
pricing flexibility will continue to drive greater adoption of our products. Our OviTex PRS products are
priced below leading biologic matrices, and as we further commercialize our OviTex PRS portfolio, we
anticipate that our customers will realize cost savings over biologic matrices based on national average
competitive pricing. We believe that the average selling prices across our products will provide financial
benefits to our customers in addition to improving clinical outcomes.
● Established reimbursement pathway for hernia repair. The implantation of biologic matrices and synthetic
mesh for hernia repair is coded using an established fixed procedure payment system known as a MS-DRG
that consists of a lump sum payment rate that varies based on the degree of complications and comorbidities
of each hernia. In addition, surgeons receive payment for their services depending on the coding associated
with the procedure. The MS-DRG-based reimbursement system encourages hospitals to become more
efficient in treating patients due to its fixed per-patient reimbursement nature.
● Broad intellectual property portfolio. Our products are covered by intellectual property that broadly covers
changing a biologic matrix’s biomechanical properties by interweaving a polymer thread through the biologic
matrix. Specifically, our patents claim the ability to tailor stretch resistance. The ability to predictably control
the biomechanical properties of a biologic matrix is the cornerstone of our product portfolio. Our intellectual
property also covers the development of extracellular matrix scaffolds derived from ovine rumen, methods
for isolating these scaffolds from ovine rumen, layering multiple sheets of these ovine rumen scaffolds
together, sewing in an anti-adhesive layer into a scaffold, and adding unique patterns sewn or embroidered
into these scaffolds using different polymers to impart reinforcing strength. Our portfolio also includes
patents covering implants with gripping strands, and implants with multivesicular liposomes that may be
used to deliver drugs. Through the Aroa License and our issued or allowed patents and patent applications,
we have a broad portfolio of intellectual property that is leveraged in all of our reinforced tissue matrix
products. In addition, we believe that the trade secrets developed with Aroa create additional barriers to entry.
● Highly accomplished executive team with proven track record. Our executive team consists of seasoned
medical device professionals with deep industry experience, and a broad network of relationships within the
industry and the medical community. Our executive team has led and managed companies through
significant growth and introduction and commercialization of multiple new products, including driving
surgeon adoption of biologic and biosurgery technologies. Members of our team have held leading positions
with medical technology companies such as Orthovita Inc., Stryker Corporation, OraSure Technologies, Inc.,
LifeCell and Medtronic plc. We believe this team is well-positioned to lead us through the commercial
expansion of our products and development and launch of future products.
Our Growth Strategy
Our goal is to become the leading provider of soft-tissue reconstruction products. The key elements of our strategy include:
● Expand our U.S. commercial organization to support our growth. We sell our products through a single
direct sales organization in the U.S. As of December 31, 2023, we had 91 sales territories in the U.S. which
are supported by 166 employees in our U.S. based commercial organization. We plan to continue to invest
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in our commercial organization by hiring additional territory managers and administrative and field-based
support employees to support and service new accounts for soft-tissue reconstruction procedures. We believe
we can also enhance the productivity of our sales force by improving customer segmentation and targeting,
implementing and further refining our proprietary training programs, leveraging support from our medical
education and medical affairs functions to drive physician awareness and education on our products, and
utilizing engagement analytics to support product development.
● Promote awareness of our products to drive surgeon use. We educate surgeons regarding the value
proposition of our products through presentations and exhibits at industry conferences, medical education
symposia, direct training and education, webinars and publishing additional clinical data demonstrating the
benefits of our products and establishing online peer-to-peer communities. We plan to continue to drive
awareness of our products through in-person and virtual versions of these programs, while expanding their
geographic reach and increasing the number of surgeon interactions. We will continue to increase our digital
marketing efforts as well to build brand awareness with event marketing engagement, targeted ads and
emails, various social media efforts and patient education and outreach efforts.
● Drive utilization through existing GPO and IDN contracts and secure additional contracts. We are focused
on partnering with our existing GPO- and IDN-contracted customers to promote implementation of our
contracts, increase our access to surgeon customers, broaden awareness of products and help drive utilization
of our products within associated hospitals and healthcare systems. To date, we have contracted with three
national GPOs covering our OviTex and OviTex PRS products. In addition, we continue to pursue contracts
with additional GPOs and IDNs. GPO and IDN contracts enable greater access to geographies with high
procedural volumes and provide prioritized status within hospital procurement systems.
● Continue to build upon clinical evidence of the effectiveness and safety of our products. We are committed
to evidence-based medicine and investing in clinical data to support the use of our products. In our BRAVO
study, the recurrence rate at the 24-month time point was 2.6%, and SSOs were observed in 38% of the study
population. 78% of all enrolled patients were characterized as high risk for experiencing an SSO based on at
least one known risk factor, which included obesity, active smoking, COPD, diabetes mellitus, coronary
artery disease, or advanced age (≥75 years). Our analysis of patients in the BRAVO study reaching 24-month
follow-up was published in the Annals of Medicine and Surgery in October 2022. We have begun our next
post-market prospective study, BRAVO II, which evaluates OviTex LPR, OviTex Core Permanent and
OviTex 1S Permanent in the robotic repair of ventral and inguinal hernias over 24 months.
● Advance our portfolio of reinforced tissue matrices with the introduction of new product features and
designs. We plan to continue to expand our product offerings and the treatment capabilities of our products to
address a broader patient base within soft-tissue reconstruction. As we innovate and develop our products,
the new features and improved surgical techniques expand the clinical applications for soft-tissue
reinforcement. Areas of focus include enhanced surgical handling, increased permeability, and longer-acting
resorbable polymers. Improving the surgical handling and implementation of our devices benefits both the
clinician and patient. Increasing product permeability encourages a more-natural healing response. Longer-
acting polymers can provide additional support for patients that need more time to heal. We believe these
technology enhancements will continue to bolster our portfolio and expand the successful use of our
products.
● Expand our service offerings and diversify our supplier base to create a broader soft tissue preservation
and restoration portfolio. We plan to continue assessing internal development strategies and strategic
partnerships with medical device companies whereby we may enter into distribution, product development
and/or licensing agreements for new soft tissue preservation and restoration products complimentary to, or
related to, existing and future products in our distribution channel. For example, in September 2023, we
entered into a distribution agreement with Advanced Medical Solutions Limited, a company registered in
England, to be their exclusive distributor of certain hernia mesh fixation devices in the U.S. In March 2024,
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we announced the full commercial launch of the LiquiFix Hernia Mesh Fixation Devices (LiquiFix FIX8™
and LiquiFix Precision™) in the U.S. Similarly, we continue to evaluate additional product opportunities that
address patient health and unmet needs within the indications in which we operate.
Our Products
Our Technology Platform
Our advanced reinforced tissue matrix technology consists of multiple layers of minimally-processed, decellularized
extracellular matrix derived from ovine rumen with interwoven polymer fibers in a unique embroidered pattern. The
extracellular matrix is the collagen component of the rumen that is retained following removal of the epithelium, muscle
and cellular content, and has an optimal biomechanical profile and open collagen architecture that allows for rapid cellular
infiltration. These thin, strong layers of ovine rumen are plentiful in supply and serve as building blocks from which we
can construct multilayered devices to customize products to adapt to clinical needs and surgeon preferences. The layers of
extracellular matrix provide a high degree of surface area for tissue remodeling. We strengthen these reinforced tissue
matrix layers with interwoven polymers, that are either permanent (polypropylene), or resorbable (PGA or PLGA). These
polymers were selected because they are well characterized suture materials with a history of significant clinical use and
recognized safety profiles. Polypropylene has a high tensile strength and a low inflammatory response in small quantities.
PGA is the fastest resorbing polymer and within three months it tends to be fully absorbed into the body, whereas using
PLGA in our products provides a slower absorption option of approximately six months.
Our highly specialized and customizable textile engineering capability allows us to tailor the degree and direction of
stretch, overall strength, handling properties, permeability, thickness, texture, size and shape of each reinforced tissue
matrix to suit the needs of particular clinical applications and surgical techniques. Our textile engineering utilizes a
computer-controlled fabrication method that is scalable, reproducible, efficient and customizable. This embroidery process
creates hundreds of micro-channels to allow the multi-directional passage of the patients’ native cells and fluids throughout
the product. The interwoven polymers are embroidered using a lockstitch pattern, which allows for the device to be
trimmed while minimizing unraveling (when cut), and we use a patented corner-lock pattern, which creates a stable
polymer fabric within the biologic material. We manipulate the polymer thread patterns to control the degree and stretch of
our products. Denser grid patterns increase the amount of reinforcement and less dense patterns of different geometry allow
for greater stretch. We are also able to manufacture products with smooth external layers that minimize the amount of
exposed polymer such that the product can be placed in contact with the viscera.
OviTex Reinforced Tissue Matrix
Our OviTex Reinforced Tissue Matrix has received 510(k) clearance from the FDA, which clearance was obtained and is
currently held by Aroa and is intended for use as a surgical mesh to reinforce and/or repair soft-tissue where weakness
exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or
bridging material to obtain the desired surgical outcome. Our OviTex products can be used in a variety of hernia repairs,
including simple and complex ventral, inguinal and hiatal hernias, as well as abdominal wall reconstructions.
Our OviTex products are sterile reinforced tissue matrices derived from ovine rumen with either polypropylene or PGA.
The product is provided in a dry, hydratable form and packaged in a double pouched configuration. The product can be
stored at room temperature and only needs five minutes of rehydration for use. To be used in surgery our OviTex product is
placed in a sterile dish, rehydrated with sterile saline for five minutes, trimmed to fit the site, if needed, and then positioned
to achieve maximum contact between the device and the surrounding tissue. The device may be sutured, stapled or tacked
into place.
All of our OviTex products were designed to minimize the amount of polymer material implanted in patients. The synthetic
material in our OviTex products comprise less than 5% of our final product or approximately 12% in our OviTex LPR
devices. Depending on the configuration selected, the amount of polymer is approximately 75% less than the polymer
content of the most widely implanted permanent synthetic mesh, thereby reducing the patient’s foreign body inflammatory
response to the polymer.
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We market a variety of OviTex products in a range of sizes, thicknesses and degrees of reinforcement in order to suit
surgeon preference and desired surgical technique. Our OviTex portfolio is designed to allow surgeons to select a device
appropriate for any abdominal tissue plane. Generally, surgeons may place the reinforced tissue matrix in direct contact
with internal organs, known as intraperitoneal placement, or away from these internal organs in a variety of tissue planes,
known as pre-peritoneal placement. When selecting a product for intraperitoneal placement, surgeons require a surface that
minimizes the risk of tissue attachment, whereas when selecting a product for pre-peritoneal placement, surgeons are able
to use a product with polymer exposure on both sides. Surgeons may select the most appropriate product from our OviTex
portfolio based on the size of the defect, necessity or surgeon preference for internal organ contact, use of a minimally
invasive or open surgical technique and risk of infection.
OviTex Laparoscopic and Robotic Procedures
Our OviTex LPR product was specifically designed for use in laparoscopic and robotic-assisted hernia surgical repairs.
OviTex LPR was designed for use with a trocar and requires the same rehydration and fixation as our other OviTex
products. This product includes design elements to improve surgical handling, including two extra embroidered lines of
blue colored polypropylene fibers (ellipse shapes) to enhance endoscopic orientation and alignment. This product can be
introduced into the patient’s body through various sized trocar ports. Based on surgeon feedback, OviTex LPR was
designed in an elliptical or circular shape to minimize trimming.
OviTex Portfolio
OviTex
OviTex 1S
OviTex 2S
OviTex LPR
Size and Shape
4 × 8 cm to 25 × 40 cm*
(Rectangle or Square)
4 × 8 cm to 25 × 40 cm*
(Rectangle or Square)
4 × 8 cm to 25 × 40 cm*
(Rectangle or Square)
Strength
Layers of Ovine
Rumen
Common
Procedures
Polymer
Shelf Life
Configuration
Commercial
Availability
+
Four
++
Six
+++
Eight
Moderate ventral hernia
(pre-peritoneal placement),
inguinal hernia, hiatal hernia
Moderate to complex ventral
hernia, can be placed
intraperitoneally
Resorbable (PGA) or
Permanent (Polypropylene)
Resorbable-18 months
Permanent-36 months
Exposed polymer on both
sides
·
·
U.S.
Europe
Resorbable (PGA) or
Permanent (Polypropylene)
Resorbable-18 months
Permanent-36 months
Exposed polymer on one
side, and one smooth side
·
·
U.S.
Europe
Complex ventral hernia and
abdominal wall
reconstruction and can be
used for bridging, can be
placed intraperitoneally
Resorbable (PGA) or
Permanent (Polypropylene)
Resorbable-18 months
Permanent-36 months
Two smooth sides
·
·
U.S.
Europe
12 × 18 cm to 15 x 25 cm
(Ellipse); 9 cm to 15 cm
(Round)
+
Four
Laparoscopic or Robotic-
assisted surgery
Permanent (Polypropylene)
36 months
Exposed polymer on one
side, and one smooth side
·
·
U.S.
Europe
*
25 x 30 cm and 25 x 40 cm sizes currently only available with permanent (polypropylene) polymer.
+ Denotes relative level of strength.
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OviTex Plastic and Reconstructive Surgery — OviTex PRS
OviTex PRS, has received 510(k) clearance from the FDA, which clearance was obtained by Aroa and is held by us, and is
indicated for use in implantation to reinforce soft-tissue where weakness exists in patients requiring soft-tissue repair or
reinforcement in plastic and reconstructive surgery. In March 2023, we received an additional 510(k) clearance, which
expands the OviTex PRS portfolio to include OviTex PRS Long-Term Resorbable. Our OviTex PRS portfolio can be stored
at room temperature and comes in the same packaging and requires the same rehydration and fixation as our OviTex
products.
Our OviTex PRS portfolio is a sterile reconstructive reinforced tissue matrix that comes in three different options. The
short-term resorbable and permanent PRS options are composed of two or three layers of ovine rumen joined by a patented
corner-lock embroidered diamond patterned polymer (PGA or polypropylene) that allows the product to stretch uni-
directionally while also maintaining its shape. Machine punched regularly spaced fenestrations, or holes and die-cut slits in
the product facilitate fluid management, allow for rapid cellular infiltration and create a directional bias to the stretch. The
third option, the long-term resorbable PRS, provides bi-directional stretch and longer resorption profile utilizing PLGA.
Our OviTex PRS product is available in arced rectangle, contour and oval shapes in a range of sizes (4 × 16 cm through
20 × 25 cm) to suit surgeon preference and nature of the soft-tissue repair in plastic and reconstructive surgery. The device
may be trimmed to a desired shape to further accommodate individual anatomy. The current shelf life of permanent OviTex
PRS is 36 months and the current shelf life of resorbable OviTex PRS is 12 months.
OviTex PRS
Product Pipeline and Research and Development
We continue to advance our product pipeline to broaden our treatment capabilities for soft-tissue reinforcement. As we
innovate and develop our products, the new features and improved surgical techniques expand the clinical applications for
soft-tissue reinforcement. Areas of focus include enhanced surgical handling, increased permeability, and longer-acting
resorbable polymers. Improving the surgical handling and implementation of our devices benefits both the clinician and
patient. Increasing product permeability encourages a more-natural healing response. Longer-acting polymers can provide
additional support for patients that need more time to heal. In addition, we continue to explore the development of lower-
cost, higher margin resorbable polymer-based devices targeting our current indications. We
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believe these technology enhancements and new product alternatives will continue to bolster our portfolio and expand the
successful use of our products across a variety of soft-tissue surgical applications.
Scientific Evidence
Overview of Preclinical and Clinical Programs
One of our key strategies is to continuously obtain evidence to support the safety and effectiveness of our products, which
we believe will differentiate us from our competitors. As part of our strategy to gather and analyze high-quality data, we
seek to ensure rigorous and reliable data collection and reporting. The data from our preclinical and clinical studies
strengthens our ability to raise surgeon awareness and drive adoption of our products as a new category of soft-tissue
reconstruction products. We expect our clinical evidence will provide surgeons with safety and efficacy data on the
appropriate use of our products and we plan to obtain further clinical evidence to support additional regulatory clearances
or approvals of our reinforced tissue matrices for additional indications for use in the future.
Preclinical Program
Our pre-clinical program is paramount in the design of our products. Our program starts with bench performance
characterization to ensure proper strength and compliance for the indication, followed by in-vitro and in-vivo studies to
ensure proper biological performance to help promote remodeling of the repair site. We have developed an extensive pre-
clinical research library on our devices, as well as on competitor devices. We continue to evaluate new and existing
technologies for safety and biocompatibility as part of our product development process.
We believe we have completed the largest collection of non-human primate preclinical studies conducted in soft-tissue
reconstruction surgery. In these studies, we compared our OviTex and OviTex PRS products to market leading competitive
materials. The results showed our reinforced tissue matrices exhibited a minimal inflammatory response, rapid cellular
infiltration and revascularization and demonstrated early and complete remodeling into functional tissue. The OviTex
results have been published in the peer-reviewed journal Hernia (https://doi.org/10.1007/s10029-019-02119-z). The OviTex
PRS results have been published in the peer-reviewed journal ePlasty (ePlasty 2022;22:e43).
Clinical Program
We are committed to obtaining evidence to support the safety and efficacy of our products across their indications. Clinical
data has been published on over 1,000 patients treated with OviTex in ventral hernia, inguinal hernia, hiatal hernia, and
abdominal wall reconstruction. As part of our clinical research program, we have developed two post-market studies,
BRAVO and BRAVO II. This commitment to generating clinical data through controlled prospective studies with 24-
month follow-up will allow us to understand the short- and long-term benefits of using OviTex in hernia repair.
In October 2022, the 24-month results of our BRAVO study were published in the Annals of Medicine and Surgery. The
BRAVO study was designed to evaluate the clinical performance of OviTex for primary or recurrent ventral hernias using
open, laparoscopic, or robotic techniques in 92 enrolled patients. The recurrence rate at the 24-month time point was 2.6%,
and SSOs were observed in 38% of the study population. 78% of all enrolled patients were characterized as high risk for
experiencing an SSO based on at least one known risk factor, which included obesity, active smoking, COPD, diabetes
mellitus, coronary artery disease, or advanced age (≥75 years). The results also indicated that BRAVO patients experienced
statistically significant and clinically meaningful improvements in their quality of life and perceived health.
Surgeons continue to use our OviTex PRS reinforced tissue matrices in their surgeries and, in addition to a potential IDE
study, we have also commenced a retrospective clinical study evaluating the effectiveness and safety of our OviTex PRS
products.
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Intellectual Property
Our success depends in part on our ability to obtain, maintain, protect and enforce our proprietary technology and
intellectual property rights, in particular, our patent and trademark rights, preserving the confidentiality of our trade secrets,
and operating without infringing the valid and enforceable patents and other proprietary rights of third parties. We rely on a
combination of patent, trademark, trade secret and other intellectual property rights and measures to protect the intellectual
property rights that we consider important to our business. We also rely on know-how and continuing technological
innovation to develop and maintain our competitive position.
Aroa License
In August 2012, we entered into the Aroa License, which was amended and restated in July 2015, pursuant to which we
obtained an exclusive license to certain patents and know-how to develop, commercialize and sell bovine and ovine
extracellular matrix products for hernia repair, abdominal wall and breast reconstruction in North America and Europe,
which we refer to as the Licensed Territory. In addition, under the Aroa License, Aroa is our exclusive manufacturer and
supplier for the development of our bovine and ovine extracellular matrix products.
Pursuant to the terms of the Aroa License, we made upfront payments to Aroa totaling $2.3 million and granted Aroa
74,316 newly issued shares of our restricted common stock. We have made additional payments in the aggregate of
$2.0 million to Aroa following the achievement of certain regulatory and operational milestones, including FDA
510(k) clearance of our OviTex products, which clearance was obtained and is currently held by Aroa, for use in surgical
soft-tissue reinforcement and the receipt of the first CE mark for sale of our products in the European Economic Area for
use in abdominal wall reconstruction and hernia repair and our acceptance of certain supply quantities manufactured by
Aroa for our commercial launch in Europe. In addition, we paid Aroa $4.0 million in revenue-based milestone payments
upon our achievement of certain net sales thresholds for sales of our products within the Licensed Territory. As of
December 31, 2022, we had satisfied all milestone payment obligations under the Aroa License.
We are responsible for commercializing the products manufactured for us by Aroa. We pay Aroa for the supply and
manufacturing of our products through a revenue sharing agreement. Pursuant to the Aroa License, we purchase product
from Aroa at a fixed transfer cost as a percentage of Aroa’s cost of goods, which, with the exception of our recent IHR-
dedicated products, equals 27% of our net sales of licensed products. For the IHR-dedicated products, this revenue share
arrangement may be limited on an annual basis to ensure that Aroa retains at least the aggregate transfer pricing we pay for
such products. If at any point during the term of the Aroa License we and Aroa determine that our anticipated product
needs exceed Aroa’s manufacturing capabilities, we and Aroa will mutually approve an expansion and equally share the
cost of such expansion. Our share of such expansion costs may be offset by us against future revenue share payments.
The initial term of the Aroa License terminates on the expiration of the last patent covering the OviTex and OviTex PRS
products, currently March 9, 2031, with an option to extend for an additional ten-year period. Either party may terminate
the Aroa License upon the other party’s material breach, subject to a ninety-day notice and cure period or upon thirty-days
written notice in the event of bankruptcy. We may terminate manufacture and production of a specific product upon thirty-
days prior written notice upon (i) a reasonable determination that such product infringes the intellectual property rights of a
third party, (ii) an uncured supply failure by Aroa or (iii) such product proves unfeasible, and immediately upon written
notice from a regulatory authority that such product must be withdrawn from the market. If we materially breach the Aroa
License in one of the Licensed Territories, Aroa may terminate the Aroa License solely with respect to the Licensed
Territory in which the breach occurred. Upon termination of the Aroa License, we have the right to purchase all or any part
of the unsold portion of any completed products from Aroa and the right to continue to sell all products remaining in our
inventory.
The Aroa License also contains customary representations and warranties, confidentiality, insurance, audit, indemnification
and non-competition provisions.
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Patents
As of December 31, 2023, we exclusively license two issued U.S. patents that will expire in 2029 and 2031. We own
seventeen U.S. issued or allowed patents which will expire between 2035 and 2041 and sixteen pending U.S. patent
applications, which subject to issuance, are projected to expire between 2035 and 2044, without taking into account
potential patent term extensions or adjustments. In addition to our U.S. intellectual property, we also own five issued non-
U.S. patents and three pending non-U.S. patent applications, which, subject to issuance, would be projected to expire
between 2036 and 2040 and have exclusively licensed issued patents in Europe and Canada that will expire in 2029.
Our patents and patent applications cover, among other things, our corner-lock embroidery pattern, the use of adhesion
barriers sewn into soft-tissue and compliance associated with stretching.
Although the term of individual patents varies depending upon the country in which they were granted, in most countries,
including the U.S., the patent term is 20 years from the earliest claimed filing date of a non-provisional patent application
in the applicable country. In the U.S., a patent’s term may, in certain cases, be lengthened by patent term adjustment, which
compensates a patentee for administrative delays by the U.S. Patent and Trademark Office in examining and granting a
patent, or may be shortened if a patent is terminally disclaimed over a commonly owned patent or a patent naming a
common inventor and having an earlier expiration date.
We cannot be sure that our pending patent applications that we have filed or may file in the future will result in issued
patents, and we can give no assurance that any patents that have been issued or might issue in the future will protect our
current or future products, will provide us with any competitive advantage, and will not be challenged, invalidated, or
circumvented.
Trade Secrets
We seek to protect our proprietary rights through a variety of methods, including confidentiality agreements and
proprietary information agreements with suppliers, employees, consultants and others who may have access to our
proprietary information. However, trade secrets and proprietary information can be difficult to protect. While we have
confidence in the measures we take to protect and preserve our trade secrets and proprietary information, such measures
can be breached, and we may not have adequate remedies for any such breach. In addition, our trade secrets and
proprietary information may otherwise become known or be independently discovered by competitors.
Trademarks
We also rely on trademarks and trade designs to develop and maintain our competitive position. TELA Bio®, OviTex®,
Minimize the Foreign Body Footprint®, and A More Natural Hernia Repair® are registered trademarks of ours in the U.S.
and TELA Bio® and OviTex® are registered trademarks in the foreign jurisdictions in which we conduct our business.
For more information regarding the risks related to our intellectual property, please see the section titled “Risk Factors —
Risks Related to Intellectual Property Matters.”
Research and Development
We invest in research and development to advance our reinforced tissue matrix products and to develop complimentary soft
tissue preservation and restoration products, with the goal of improving upon and supplementing our existing product
offerings. We believe our ability to rapidly develop new products and product configurations is attributable to the dynamic
product innovation process that we have implemented, the versatility and leveragability of our core technology and the
management philosophy behind that process. We have recruited and retained engineers and scientists with significant
experience in the development of polymer science, biologics, textile engineering and analytical testing. We have a number
of design improvements for our reinforced tissue matrices in various stages of development that are expected to enhance
our current products and increase surgeon adoption of our products. In addition, we have engaged in discussions with the
FDA regarding an IDE protocol to study the safety and effectiveness of our OviTex PRS portfolio
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for an indication in breast reconstruction surgery. The FDA has stated that a PMA, rather than 510(k) clearance, will be
required for such an indication. Our research and development efforts are based at our facility in Malvern, Pennsylvania.
Commercial Strategy
Our commercial efforts are predominantly focused on the U.S. market where we have established strong relationships with
key constituencies, including hospitals, ambulatory surgery centers, GPOs, IDN, third-party payors and other key clinical
and economic decision makers by offering a unique high quality, cost-effective product. As part of our overall commercial
strategy, we intend to contract with GPOs and IDNs to increase access and penetration with hospital accounts. To date, we
have contracted with three national GPOs for coverage of our OviTex and OviTex PRS products. We have invested in our
direct sales and marketing infrastructure in order to expand our presence to promote awareness and adoption of our
products.
We market our products to hospitals, ambulatory surgery centers, surgeons, GPOs, IDNs and medical device supply chain
participants primarily through our direct sales force. Our sales representatives and sales managers have substantial medical
device experience. As of December 31, 2023, we had 166 employees in our U.S. based commercial organization in 91 sales
territories, which includes sales management, territory managers, marketing and administrative and field-based support
staff. We plan to continue to invest in our commercial organization by hiring additional territory managers and
administrative and field-based support employees to support and service new accounts for soft-tissue reconstruction
procedures.
Manufacturing
The majority of our raw materials are sourced through and manufactured by Aroa in their Auckland, New Zealand facility
under the terms of the Aroa License. Aroa’s facility is approximately 40,000 square feet of which approximately 25,000
square feet is dedicated to manufacturing, including an additional 15,000 square feet of additional manufacturing space in a
neighboring facility. The Auckland facility is FDA registered and ISO 13485 certified. We believe that Aroa will be
capable of providing sufficient quantities of our products to meet anticipated customer demands. In the event of an uncured
supply failure by Aroa, we have the right to, directly or through a third-party, step in and operate the Aroa Auckland
facility to manufacture our products on behalf of Aroa.
The proprietary ovine rumen used in the manufacturing of our products is obtained from sheep raised for human
consumption in New Zealand and is currently sourced by Aroa from two abattoirs, or slaughterhouses. Although only two
abattoirs are currently qualified, there are more than 30 additional abattoirs in New Zealand that could be used to source
the ovine rumen. New Zealand cattle and sheep are considered by the USDA to be free of prion disease (progressive
neurodegenerative disorders, including scrapie). The sheep receive veterinary inspection prior to slaughter and then each
carcass is inspected post-mortem for the presence of disease according to USDA approved standards. Only sheep which
pass full inspection can be used as a raw tissue source for our products and all the ovine rumen is processed in compliance
with the FDA’s regulations for Medical Devices Containing Materials Derived from Animal Sources. Once the ovine
rumen is procured, our reinforced tissue matrix products are then manufactured by Aroa at its facility in Auckland, New
Zealand.
Distribution
The majority of our products are shipped directly from Auckland, New Zealand to our headquarters in Malvern,
Pennsylvania. We sell our products directly to our customers, which are hospitals and ambulatory surgery centers. Except
for our stocking distributors in Europe, we do not use distributors to sell our products.
Competition
The medical device industry is intensely competitive, subject to change and significantly affected by new product
introductions and other market activities of industry participants.
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In the hernia repair market, our primary competitors are Bard, a subsidiary of Becton, Dickinson and Company, which
produces Phasix and Ventralight ST, and LifeCell, a subsidiary of AbbVie, which produces Strattice. In the plastic and
reconstructive surgery market, our primary competitors are LifeCell, a subsidiary of AbbVie, which produces AlloDerm,
MTF Biologics, which produces FlexHD and RTI Surgical, which produces Cortiva.
Many of these competitors are large, well-capitalized companies with significantly greater market share and resources than
we have, selling products that have been on the market prior to the commercialization of our products. As a consequence,
they are able to spend more on product development, marketing, sales and other product initiatives than we can, while also
benefiting from greater brand awareness. We also compete with smaller medical device companies that have single
products or a limited range of products. Some of our competitors have:
● significantly greater name recognition;
● broader or deeper relations with healthcare professionals, customers and third-party payors;
● more established distribution networks;
● greater experience in conducting research and development, manufacturing, clinical trials, marketing and
obtaining regulatory clearance or approval for products; and
● greater financial and human resources for product development, sales and marketing and patent prosecution.
We believe that our continued ability to compete favorably depends on:
● successfully expanding our commercial operations;
● continuing to innovate and maintain scientifically-advanced technology;
● attracting and retaining skilled personnel;
● maintaining and obtaining intellectual property protection for our products; and
● conducting clinical studies and obtaining and maintaining regulatory approvals.
Government Regulation
Our products and operations are subject to extensive and rigorous regulation by the FDA and other federal, state and local
authorities, as well as foreign regulatory authorities. The FDA regulates, among other things, the research, development,
testing, design, manufacturing, approval, labeling, storage, recordkeeping, advertising, promotion and marketing,
distribution, post-approval monitoring and reporting and import and export of medical devices in the U.S. to assure the
safety and effectiveness of medical products for their intended use. The Federal Trade Commission also regulates the
advertising of our products in the U.S. Further, we are subject to laws directed at preventing fraud and abuse, which subject
our sales and marketing, training and other practices to government scrutiny.
Regulatory System for Medical Devices in the U.S.
All of our medical devices sold in the U.S. are subject to the Federal Food, Drug, and Cosmetic Act (“FDCA”) as
implemented and enforced by the FDA.
Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the
U.S. will require either a premarket notification to the FDA requesting permission for commercial distribution under
Section 510(k) of the FDCA also referred to as a 510(k) clearance, or approval from the FDA of a PMA application.
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Both the 510(k) clearance and PMA processes can be resource intensive, expensive, and lengthy, and require payment of
significant user fees, unless an exemption is available.
Device Classification
Under the FDCA, medical devices are classified into one of three classes — Class I, Class II or Class III — depending on
the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances
with respect to safety and effectiveness.
Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be
reasonably assured by adherence to a set of FDA regulations, referred to as the General Controls for Medical Devices,
which require compliance with the applicable portions of the Quality Systems Regulations, or QSR, facility registration
and product listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling
and promotional materials. Some Class I devices, also called Class I reserved devices, also require premarket clearance by
the FDA through the 510(k) premarket notification process described below. Most Class I products are exempt from the
premarket notification requirements.
Class II devices are those that are subject to the General Controls, and special controls as deemed necessary by the FDA to
ensure the safety and effectiveness of the device. These special controls can include performance standards, patient
registries, FDA guidance documents and post-market surveillance. Most Class II devices are subject to premarket review
and clearance by the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the
510(k) premarket notification process.
Class III devices include devices deemed by the FDA to pose the greatest risk such as life-supporting or life-sustaining
devices, or implantable devices, in addition to those deemed novel and not substantially equivalent to a medical device
cleared through the 510(k) process. The safety and effectiveness of Class III devices cannot be reasonably assured solely
by the General Controls and special controls described above. Therefore, these devices are subject to the PMA application
process, which is generally more costly and time consuming than the 510(k) process. Through the PMA application
process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness
of the device for its intended use to the FDA’s satisfaction. Accordingly, a PMA application typically includes, but is not
limited to, extensive technical information regarding device design and development, preclinical and clinical trial data,
manufacturing information, labeling and financial disclosure information for the clinical investigators in device studies.
The PMA application must provide valid scientific evidence that demonstrates to the FDA’s satisfaction a reasonable
assurance of the safety and effectiveness of the device for its intended use.
510(k) Clearance Pathway
Our current products are subject to premarket notification and clearance under section 510(k) of the FDCA.
When a 510(k) clearance is required, we must submit a premarket notification to the FDA demonstrating that our proposed
device is substantially equivalent to a predicate device, which is a previously cleared and legally marketed 510(k) device or
a device that was in commercial distribution before May 28, 1976 (pre-amendments device) and for which a PMA is not
required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially
equivalent through the 510(k) process. By regulation, a premarket notification must be submitted to the FDA at least
90 days before we intend to distribute a device. As a practical matter, clearance often takes nine to twelve months, but may
take significantly longer. To demonstrate substantial equivalence, the manufacturer must show that the proposed device has
the same intended use as the predicate device, and it either has the same technological characteristics, or different
technological characteristics and the information in the premarket notification demonstrates that the device is as safe and
effective as the predicate device and does not raise different questions of safety and effectiveness. The FDA may require
further information, including clinical data, to make a determination regarding substantial equivalence.
If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant
510(k) clearance to commercially market the device. If the FDA determines that the device is “not substantially
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equivalent” to a previously cleared device, the device is automatically designated as a Class III device. The device sponsor
must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in
accordance with the de novo classification procedure, which is a route to market for novel medical devices that are low to
moderate risk and are not substantially equivalent to a predicate device.
After a device receives 510(k) marketing clearance, any modification that could significantly affect its safety or
effectiveness, or that would constitute a major change or modification in its intended use, will require a new
510(k) marketing clearance or, depending on the modification, a de novo classification or PMA approval. The FDA
requires each manufacturer to determine whether the proposed change requires a premarket submission in the first instance,
but the FDA can review any such decision and disagree with a manufacturer’s determination.
Many minor modifications today are accomplished by a manufacturer documenting the change in an internal letter-to-file.
The letter-to-file is in lieu of submitting a new 510(k) to obtain clearance for every change. The FDA can always review
these letters-to-file in an inspection. If the FDA disagrees with a manufacturer’s determination, the FDA can require the
manufacturer to cease marketing and/or request the recall of the modified device until marketing authorization is obtained.
Also, in these circumstances, we may be subject to significant regulatory fines or penalties.
De Novo Classification
Medical device types that the FDA has not previously classified as Class I, II or III are automatically classified into Class
III regardless of the level of risk they pose. The Food and Drug Administration Modernization Act of 1997, or FDAMA,
established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due
to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo
classification procedure.
This procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-
classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather
than requiring the submission and approval of a PMA application. Prior to the enactment of the Food and Drug
Administration Safety and Innovation Act of 2012, or FDASIA, a medical device could only be eligible for de novo
classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the
FDA that the device was not substantially equivalent to a predicate device. FDASIA streamlined the de novo classification
pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket
notification to the FDA and receiving a not substantially equivalent determination. Under FDASIA, the FDA is required to
classify the device within 120 days following receipt of the de novo application, although the review of an application can
occur over a significantly longer period of time. If the manufacturer seeks reclassification into Class II, the manufacturer
must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and
effectiveness of the medical device. In addition, the FDA may reject the reclassification petition if it identifies a legally
marketed predicate device that would support a 510(k) or determines that the device is not low to moderate risk or that
general controls would be inadequate to control the risks and special controls cannot be developed.
The PMA Approval Process
Class III devices require PMA approval before they can be marketed although some pre-amendment Class III devices for
which the FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding
than the 510(k) premarket notification process. In a PMA, the manufacturer must demonstrate that the device is safe and
effective, and the PMA must be supported by extensive data, including data from preclinical studies and human clinical
trials. The PMA must also contain a full description of the device and its components, a full description of the methods,
facilities and controls used for manufacturing, and proposed labeling. While our current products are subject to the 510(k)
clearance pathway, any future products or modifications to our existing products that we plan to develop for a breast
reconstruction indication would be subject to the PMA approval process.
Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to permit a
substantive review. If it is not, the agency will refuse to file the PMA. If it is, the FDA will accept the application for
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filing and begin the review. The FDA has 180 days to review a filed PMA application, although the review of an
application can occur over a significantly longer period of time, and can take up to several years. During this review
period, the FDA may request additional information or clarification of information already provided, or the FDA may issue
a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA.
The FDA considers a PMA or PMA supplement to have been voluntarily withdrawn if an applicant fails to respond to an
FDA request for information (e.g., a major deficiency letter) within 360 days. Before approving or denying a PMA, an
FDA advisory committee may review the PMA at a public meeting and provide the FDA with the committee’s
recommendation on whether the FDA should approve the submission, approve it with specific conditions, or not approve it.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully
when making decisions.
Prior to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as
inspections of the manufacturing facility and processes. Overall, the FDA review of a PMA application generally takes
between one and three years, but may take significantly longer.
The FDA will approve the new device for commercial distribution if it determines that the data and information in the
PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its
intended use(s).
If the FDA evaluation of a PMA is favorable, the FDA will issue either an approval letter, or an approvable letter, the latter
of which usually contains a number of conditions that must be met in order to secure final approval of the PMA. When and
if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter
authorizing commercial marketing of the device, subject to the conditions of approval and the limitations established in the
approval letter. If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the FDA will
deny approval of the PMA or issue a not approvable letter. The FDA also may determine that additional tests or clinical
trials are necessary, in which case the PMA approval may be delayed for several months or years while the trials are
conducted and data is submitted in an amendment to the PMA, or the PMA is withdrawn and resubmitted when the data are
available. The FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to
protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a
longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of
years and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions
of approval can result in material adverse enforcement action, including withdrawal of the approval.
New PMA applications or PMA supplements are required for changes to an approved device, such as modifications to the
manufacturing process, equipment or facility, quality control procedures, sterilization, packaging, expiration date, labeling,
device specifications, ingredients, materials or design. PMA supplements often require submission of the same type of
information as an initial PMA application, except that the supplement is limited to information needed to support any
changes from the device covered by the approved PMA application and may or may not require extensive technical or
clinical data or the convening of an advisory committee, depending on the nature of the proposed change.
In approving a PMA application, as a condition of approval, the FDA may also require some form of post-approval study
or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a
number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect
the public health or to provide additional or longer term safety and effectiveness data for the device. The FDA may also
require post-market surveillance for certain devices cleared under a 510(k) notification, such as implants or life-supporting
or life-sustaining devices. The FDA may also approve a PMA application with other post-approval conditions intended to
ensure the safety and effectiveness of the device, such as, among other things, restrictions on labeling, promotion, sale,
distribution and use.
The Investigational Device Process
Clinical trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission. All
clinical investigations of investigational devices to determine safety and effectiveness must be conducted in
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accordance with the FDA’s IDE regulations which govern investigational device labeling, prohibit promotion of the
investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors
and study investigators. Some types of studies deemed to present a “non-significant risk” are deemed to have an approved
IDE once certain requirements are addressed and Institutional Review Board, or IRB approval is obtained. If the device
presents a “significant risk” to human health, as defined by the FDA, the sponsor must submit an IDE application to the
FDA and obtain IDE approval prior to commencing the human clinical trials. The IDE will automatically become effective
30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA
determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may
permit a clinical trial to proceed under an approval with conditions. The IDE application must be supported by appropriate
data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing
protocol is scientifically sound. Generally, clinical trials for a significant risk device may begin once the IDE application is
approved by the FDA and the study protocol and informed consent are approved by an appropriate IRB. There can be no
assurance that submission of an IDE will result in the ability to commence clinical trials, and although the FDA’s approval
of an IDE allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the
results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.
During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial
monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse
event reporting, record keeping and prohibitions on the promotion of investigational devices or on making safety or
effectiveness claims for them. The clinical investigators in the clinical study are also subject to FDA good clinical practice
regulations and must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control
the disposition of the investigational device, and comply with all reporting and recordkeeping requirements. Additionally,
after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons,
including a belief that the risks to study subjects outweigh the anticipated benefits. The results of clinical testing may be
unfavorable, or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for
the FDA to grant marketing approval or clearance of a product.
Pervasive and Continuing FDA Regulation
After the FDA permits a device to enter commercial distribution, numerous and pervasive regulatory requirements continue
to apply to our business operations, products and technologies. These include:
● the FDA’s Quality Systems Regulations (“QSR”), which requires manufacturers, including third party
manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection,
complaint handling, documentation and other quality assurance procedures during all aspects of the
manufacturing process;
● labeling and marketing regulations which require that promotion is truthful, not misleading, fairly balanced
and provides adequate directions for use and that all claims are substantiated;
● complying with requirements for Unique Device Identifiers on devices and also requiring the submission of
certain information about each device to the FDA’s Global Unique Device Identification Database;
● advertising and promotion requirements, including FDA prohibitions against the promotion of products for
uncleared, unapproved or off-label uses and FDA guidance on off-label dissemination of information and
responding to unsolicited requests for information;
● restrictions on sale, distribution or use of a device;
● device establishment, registration and listing requirements and annual reporting requirements;
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● approval or clearance of modifications to 510(k)-cleared devices that could significantly affect safety or
effectiveness or that would constitute a major change in intended use of one of our cleared devices;
● medical device reporting regulations, which require that manufacturers report to the FDA if their device may
have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or
contribute to a death or serious injury if the malfunction were to recur;
● medical device correction, removal and recall reporting regulations, which require that manufacturers report
to the FDA field corrections and product recalls or removals if undertaken 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;
● recall requirements, including a mandatory recall if there is a reasonable probability that the device would
cause serious adverse health consequences or death;
● an order of repair, replacement or refund;
● device tracking requirements; and
● post-market surveillance activities and regulations, which apply when necessary to protect the public health
or to provide additional safety and effectiveness data for the device.
The FDA has broad post-market and regulatory enforcement powers. Medical device manufacturers are subject to
unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with the
QSR and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include
any of the following sanctions:
● warning letters, untitled letters, Form 483s, fines, injunctions, consent decrees and civil penalties;
● recall or seizure of products;
● operating restrictions, partial suspension or total shutdown of production;
● the FDA’s refusal of requests for 510(k) clearance or premarket approval of new products, new intended uses
or modifications to existing products;
● the FDA’s refusal to issue certificates to foreign governments needed to export products for sale in other
countries;
● withdrawing 510(k) clearance or premarket approvals that have already been granted; and
● criminal prosecution.
Regulatory System for Medical Devices in Europe
The European Union (“EU”) and the European Economic Area (“EEA”) (which is comprised of the 27 Member States of
the EU plus Norway, Liechtenstein and Iceland) has a coordinated system for the authorization of medical devices. Until
May 25, 2021, medical devices were regulated by the Council Directive 93/42/EEC, or the Medical Devices Directive
(“MDD”), which has been repealed and replaced by Regulation (EU) No 2017/745, or the Medical Devices Regulation
(“MDR”). There is a transition period during which certificates issued under the MDD remain valid, however, when such
certificates expire the devices must be valid under Regulation (EU) 2023/607 of 15 March 2023
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amending Regulations (EU) 2017/745 with regard to the transitional provisions for certain medical devices and in vitro
diagnostic medical devices or be certified under the new regime set forth in the MDR.
The MDR went into effect on May 26, 2021, and it:
● strengthens the rules on placing devices on the market and reinforces surveillance once they are available;
● establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality,
performance and safety of devices placed on the market;
● improves the traceability of medical devices throughout the supply chain to the end-user or patient through a
unique identification number;
● sets up a central database (Eudamed) to provide patients, healthcare professionals and the public with
comprehensive information on products available in the EU; and
● strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to
undergo an additional check by experts before they are placed on the market.
Under the MDR, the system of regulating medical devices operates by way of a certification for each medical device,
which confirms that the device meets the relevant general safety and performance requirements laid down in Annex I of the
MDR. Each certificated device is marked with a CE mark which shows that the device has a certificat de conformité, also
referred to as a certificate of conformity. The means for achieving the requirements for a CE mark varies according to the
nature of the device. Devices are classified in accordance with their perceived risks, similarly to the U.S. system. The class
of a product determines the requirements to be fulfilled in accordance with the MDR before a CE mark can be placed on a
product. The procedure by which a device is assessed to confirm if it complies with the applicable safety and performance
requirements is known as a conformity assessment. Conformity assessment procedures require an assessment of available
clinical evidence, literature data for the product, and post-market experience in respect of similar products already
marketed. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal
conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when
weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the
device are supported by suitable evidence. Except for low-risk medical devices (Class I non-sterile, non-measuring
devices), where the manufacturer can self-certify compliance with the MDR based on a self-assessment of the conformity
of its products with the applicable requirements of the MDR, a conformity assessment procedure requires the intervention
of an independent organization accredited by a member state of the EEA to conduct conformity assessments, known as a
notified body. If satisfied that the relevant product conforms to the relevant general safety and performance requirements,
the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of
conformity. The manufacturer may then apply the CE mark to the device, which allows the device to be placed on the
market throughout the EEA.
The MDR requires that before placing a device, other than a custom-made device, on the market, manufacturers (as well as
other economic operators such as authorized representatives and importers) must register by submitting identification
information to the electronic system (Eudamed), unless they have already registered, and manufacturers must assign a
unique identifier to the device and provide it along with other core data to the unique device identifier, or UDI, database.
These new requirements aim at ensuring better identification and traceability of the devices. Manufacturers are responsible
for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to date. Eudamed is
not yet fully functional, however the European Commission is aiming to have a fully functional version of the Eudamed
medical device database available in the second quarter of 2024. The Medical Device Coordination Group (MDCG) has
published guidance on administrative practices for manufacturers until Eudamed is fully functional.
Post-Brexit, the MDR does not apply in the United Kingdom (except for Northern Ireland, which under the Northern
Ireland Protocol is bound by certain EU laws). The medical device legislative framework in the United Kingdom is set out
in the Medical Devices Regulations 2002. These Regulations are based on the previous medical device directives of the
EU but have been amended so that they function properly now the United Kingdom is no longer part of the EU. The
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amended Medical Devices Regulations 2002 have introduced several changes including (but not limited to) replacing the
CE mark with a UKCA marking, requiring manufacturers outside of the United Kingdom to appoint a “UK Responsible
Person” if they place devices on the market in the United Kingdom and more wide-ranging device registration
requirements. For the time being, manufacturers can continue placing CE marked medical devices on the Great Britain
market with the appropriate transitional agreements.
Privacy and Security Laws
There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information,
including health information. Among others, the federal Health Insurance Portability and Accountability Act of 1996, as
amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations
(collectively referred to as “HIPAA”) establish privacy and security standards that limit the use and disclosure of protected
health information (“PHI”) and require covered entities and business associates to implement administrative, physical, and
technical safeguards to ensure the confidentiality, integrity and availability of individually identifiable health information in
electronic form, among other requirements.
Violations of HIPAA may result in civil and criminal penalties. Companies subject to HIPAA must also comply with
HIPAA’s breach notification rule which requires notification of affected patients and the U.S. Department of Health and
Human Services (“HHS”) and in certain cases of media outlets, in the case of a breach of unsecured PHI. The regulations
also require business associates of covered entities to notify the covered entity of breaches by the business associate. State
attorneys general also have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA
standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in
misusing personal information. In addition, HIPAA mandates that HHS conduct periodic compliance audits of HIPAA
covered entities and their business associates for compliance.
Many states have laws that protect the privacy and security of sensitive and personal information, including health
information, to which we are subject. These laws may be similar to or even more protective than HIPAA and other federal
privacy laws. For example, California enacted the California Consumer Privacy Act (“CCPA”) which creates individual
privacy rights for California consumers and increases the privacy and security obligations of entities handling certain
personal data. The CCPA went into effect on January 1, 2020, and the California Attorney General may bring enforcement
actions for violations beginning July 1, 2020. The CCPA has been amended from time to time, and it remains unclear what,
if any, further modifications will be made to this legislation or how it will be interpreted. And the CPRA, which will take
effect in most material respects on January 1, 2023, modifies the CCPA significantly, potentially resulting in further
uncertainty and requiring us to incur additional costs and expenses to comply.
We may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices
and deceptive statements about privacy and security, laws that place specific requirements on certain types of activities,
such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take
certain actions in response to a data breach.
Foreign data protection laws, including the General Data Protection Regulation, (“GDPR”) may also apply to health-
related and other personal information belonging to individuals who reside outside of the U.S. The GDPR went into effect
in the European Union in May 2018 and introduced strict requirements for processing the personal data of data subjects
residing in the European Economic Area. Companies that must comply with the GDPR face increased compliance
obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for
noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is
greater. Among other requirements, the GDPR regulates cross-border transfers of personal data and requires transferee
countries to have protections equivalent to protections available in the EU. In July 2023, the EU adopted the EU-U.S. Data
Privacy Framework (“DPF”) to facilitate cross-border transfers of data from the EU to the U.S. A company may participate
under the DPF by self-certifying and publicly committing to comply with the applicable DPF principles.
Further, the United Kingdom’s exit from the European Union, referred to as Brexit, has created uncertainty regarding data
protection regulation in the United Kingdom. The United Kingdom has transposed the GDPR into domestic law with a
United Kingdom version of the GDPR that took effect in January 2021 (“UK GDPR”). Currently, the GDPR and
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UK GDPR remain largely aligned, but the United Kingdom has announced plans to reform the country’s data protection
legal framework in its Data Reform Bill, which will introduce significant changes from the GDPR. This may lead to
divergence between the GDPR and UK GDPR.
EU member states have introduced national laws implementing the GDPR which impose additional requirements; this
adds to the complexity of processing personal data in or from the EEA or United Kingdom. Guidance on implementation
and compliance practices are often updated or otherwise revised.
Anti-Kickback Statutes
The federal Anti-Kickback Statute prohibits persons from (among other things) knowingly and willfully soliciting,
offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce the referral of an
individual, or the recommending, furnishing or arranging for a good or service, for which payment may be made under a
federal healthcare program such as Medicare or Medicaid.
Courts have interpreted the Anti-Kickback Statute quite broadly, holding that the statute will be violated if even one
purpose of a payment — though not its sole or primary purpose — is to induce an act prohibited by the statute with a
willful intent to act improperly. The statute prohibits many arrangements and practices that are otherwise lawful in
businesses outside of the healthcare industry. A person or entity does not need to have actual knowledge of the statute or
specific intent to violate it in order to have committed a violation. Prosecutors may infer intent from the surrounding
circumstances and, because courts have interpreted the statute to be violated if even one purpose of a payment is to induce
the purchase of items or services paid for by federal healthcare programs, prosecutors have broad discretion in choosing
arrangements to prosecute under the statute. There are statutory exceptions and regulatory “safe harbors” available to
protect certain appropriately structured arrangements that otherwise would implicate the Anti-Kickback Statute and those
who structure their business arrangements to satisfy all of the criteria of a safe harbor are protected from liability under the
statute. Our business is subject to these laws.
Many states have adopted anti-kickback and self-referral laws similar to the Anti-Kickback Statute; however, some of these
state prohibitions are broader in scope and apply to arrangements involving healthcare items or services reimbursed by any
source, and not only by Medicare, Medicaid or another federal healthcare program. These state laws do not always have the
same exceptions or safe harbors as the federal Anti-Kickback Statute.
False Claims Laws
The federal False Claims Act imposes liability on any individual or entity that, among other things, knowingly presents, or
causes to be presented, a false or fraudulent claim for payment by a federal healthcare program. The qui tam or
“whistleblower” provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal
government alleging that the defendant has violated the False Claims Act and to share in any monetary recovery. In
recent years, the number of lawsuits brought against healthcare industry participants by private individuals has increased
dramatically.
There are many potential bases for liability under the False Claims Act. Liability arises, primarily, when an entity
knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government, but also may
arise when an entity knowingly makes a false statement material to an obligation to pay or transmit money or property to
the federal government or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or
transmit money or property to the federal government. Various states have also enacted false claims and insurance fraud
laws that are analogous to the federal False Claims Act. Many of these state laws apply to claims submitted to any third-
party payor and are not limited to claims submitted to a federal healthcare program. The scope of these laws and the
interpretations of them vary from state to state and are enforced by state courts and regulatory authorities, each with broad
discretion. A determination of liability under such laws could result in fines and penalties and restrictions on a company’s
ability to operate in these jurisdictions.
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Transparency Laws
The federal Physician Payments Sunshine Act (“Sunshine Act”) which was enacted as part of the Patient Protection and
Affordable Care Act (“PPACA”) generally requires certain manufacturers of a drug, device, biologic or other medical
supply that is covered by Medicare, Medicaid or the Children’s Health Insurance Program and applicable GPOs to report
on an annual basis: (i) certain payments and other transfers of value given to certain healthcare professionals and teaching
hospitals and (ii) any ownership or investment interest that U.S. physicians, or their immediate family members, have in
their company. The payments required to be reported include the cost of meals provided to a healthcare professional, travel
reimbursements and other transfers of value, including those provided as part of contracted services such as speaker
programs, advisory boards, consultation services and clinical trial services. Under the statute, the federal government
makes reported information available to the public. Failure to comply with the reporting requirements can result in
significant civil monetary penalties or criminal penalties if an entity intentionally makes false statements in the reports.
There has been a recent trend of separate state regulation of payments and transfers of value by manufacturers of medical
devices to healthcare professionals and entities, however, and some state transparency laws apply more broadly than the
federal Sunshine Act. There are also an increasing number of analogous state laws that require manufacturers to file reports
with states on pricing and marketing information. Many of these laws contain ambiguities as to what is required to comply
with the laws. For example, several states have enacted legislation requiring manufacturers to, among other things,
establish and implement commercial compliance programs, file periodic reports with the state, make periodic public
disclosures on sales, marketing, pricing, clinical trials and other activities and/or register their sales representatives. Certain
state laws also regulate manufacturers’ use of physician and patient identifiable data. These laws may affect our sales,
marketing and other promotional activities by imposing administrative and compliance burdens. In addition, given the lack
of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty
provisions of the pertinent state and federal authorities. All of our activities are also potentially subject to federal and state
consumer protection and unfair competition.
Other Federal Healthcare Fraud and Abuse Laws
We may also be subject to other federal healthcare fraud and abuse laws, including provisions of HIPAA, which imposes
criminal liability and amends provisions on the reporting, investigation, enforcement, and penalizing of civil liability for,
among other things, knowingly and recklessly executing a scheme or artifice to defraud any healthcare benefit program,
including private payors, as well as knowingly and willfully falsifying, concealing or covering up a material fact by any
trick, scheme or device or making any materially false, fictitious or fraudulent statement in connection with the delivery of
or payment for healthcare benefits, items or services. A violation of this statute is a felony and may result in fines,
imprisonment or exclusion from government-sponsored programs. As with the federal Anti-Kickback Statute, a person or
entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a
violation.
Foreign Corrupt Practices Act
The Foreign Corrupt Practices Act (“FCPA”) prohibits U.S. businesses and their representatives from offering to pay,
paying, promising to pay or authorizing the payment of money or anything of value to a foreign official in order to
influence any act or decision of the foreign official in his or her official capacity or to secure any other improper advantage
in order to obtain or retain business. The FCPA also obligates companies whose securities are listed in the U.S. to comply
with accounting provisions requiring us to maintain books and records, which in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the corporation, including international subsidiaries, if any, and to
devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances regarding the
reliability of financial reporting and the preparation of financial statements. Our industry is heavily regulated and therefore
involves significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many
other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the
purchasers of pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are
subject to regulation under the FCPA. Recently, the SEC and Department of Justice have increased their FCPA enforcement
activities with respect to pharmaceutical companies. Violations could
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result in fines, criminal sanctions against us, our officers, or our employees, the closing down of our facilities, requirements
to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs,
and prohibitions on the conduct of our business. Enforcement actions may be brought by the Department of Justice or the
SEC, and recent enacted legislation has expanded the SEC’s power to seek disgorgement in all FCPA cases filed in federal
court and extended the statute of limitations in SEC enforcement actions in intent-based claims such as those under the
FCPA from five years to ten years.
International Laws
In Europe, and throughout the world, other countries have enacted anti-bribery laws and/or regulations similar to the
FCPA. Violations of any of these anti-bribery laws, or allegations of such violations, could have a negative impact on our
business, results of operations and reputation.
There are also international privacy laws that impose restrictions on the access, use, and disclosure of health information.
All of these laws may impact our business. Our failure to comply with these privacy laws or significant changes in the laws
restricting our ability to obtain required patient information could significantly impact our business and our future business
plans.
U.S. Healthcare Reform
The U.S. and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the
healthcare system. The U.S. government, state legislatures and foreign governments also have shown significant interest in
implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls
and restrictions on reimbursement.
In the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability
Reconciliation Act, or collectively the “Affordable Care Act”, substantially changed the way healthcare is financed by both
governmental and private insurers, and significantly impacts the healthcare industry. The Affordable Care Act is intended
to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against
healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new
taxes and fees on pharmaceutical and medical device manufacturers, and impose additional health policy reforms.
There have been significant ongoing judicial, administrative, executive and legislative efforts to modify or eliminate the
Affordable Care Act. For example, the Tax Act enacted on December 22, 2017, repealed the shared responsibility payment
for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code,
commonly referred to as the individual mandate. Other legislative changes have been proposed and adopted since passage
of the Affordable Care Act. The Budget Control Act of 2011, among other things, included aggregate reductions to
Medicare payments to healthcare providers of up to 2.0% per fiscal year, and will last through 2031 unless additional
Congressional action is taken. The American Taxpayer Relief Act of 2012 reduced Medicare payments to several types of
providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period
for the government to recover overpayments to providers from three to five years.
The Affordable Care Act has been subject to challenges in the courts. On June 17, 2021, the Supreme Court dismissed the
most recent challenge to the Affordable Care Act, ruling that the plaintiffs lacked standing to challenge the law as they had
not alleged personal injury traceable to the allegedly unlawful conduct. As a result, the Supreme Court did not rule on the
constitutionality of the Affordable Care Act or any of its provisions.
Further changes to and under the Affordable Care Act remain possible, but it is unknown what form any such changes or
any law proposed to replace or revise the Affordable Care Act would take, and how or whether it may affect our business
in the future.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control
healthcare costs, including price or patient reimbursement constraints, discounts, restrictions on certain product access
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and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from
other countries and bulk purchasing.
We expect that additional federal, state and foreign healthcare reform measures will be adopted in the future, any of which
could limit the amounts that federal and state governments will pay for healthcare products and services, which could result
in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing
pressures.
Coverage and Reimbursement
In the U.S. and markets in other countries, sales of any products for which we receive regulatory approval for commercial
sale will depend in part on the availability of reimbursement from third party payors. Third party payors include
government health administrative authorities, managed care providers, private health insurers, and other organizations.
These third-party payors are increasingly challenging the price and examining the cost-effectiveness of medical products
and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare
products, and there are continuing legislative and regulatory efforts by the federal government and the states to reduce the
cost of medical products and services overall. We may need to conduct expensive studies in order to demonstrate the cost-
effectiveness of our products. Our product candidates may not be considered cost-effective. Decisions regarding the extent
of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. One third-party payor’s
decision to cover a particular product or procedure using the product does not ensure that other payors will also provide
coverage for the product. Adequate third-party reimbursement may not be available to enable us to maintain price levels
sufficient to realize appropriate revenue levels. Future legislation could limit payments for medical devices, including our
products and our future products.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost
containment programs to limit the growth of government-paid health care costs, including price controls, restrictions on
reimbursement and requirements for substitution of less costly products. Adoption of government controls and measures,
and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for our
products. The marketability of any products for which we receive regulatory approval for commercial sale may suffer if the
government and third-party payors fail to provide adequate coverage and reimbursement. In addition, an increasing
emphasis on managed care in the U.S. has increased and will continue to increase the pressure on medical product and
service pricing.
Human Capital Resources
As of December 31, 2023, we had 227 employees worldwide. None of our employees are represented by a collective
bargaining agreement and we have never experienced a work stoppage. We believe we have good relationships with our
employees.
The success of our business is fundamentally connected to the well-being of our employees. Accordingly, we are
committed to their health, safety and wellness. We provide our employees and their families with access to a variety of
flexible and convenient health and wellness programs, including benefits that provide protection and security so they can
have peace of mind concerning events that may require time away from work or that impact their financial well-being; that
support their physical and mental health by providing tools and resources to help them improve or maintain their health
status and encourage engagement in healthy behaviors; and that offer choice where possible so they can customize their
benefits to meet their needs and the needs of their families.
We strive to provide a competitive mix of pay, benefits and services that help meet the needs of our employees. In addition
to salaries, these programs include variable incentive compensation plans, potential annual discretionary bonuses, stock
awards, a 401(k) Plan, healthcare and insurance benefits, health savings and flexible spending accounts, paid time off,
family leave, and flexible work schedules, among others. In addition to our broad-based equity award programs, we have
used targeted equity-based grants with vesting conditions to enhance retention of personnel.
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Corporate Information
We were incorporated on April 17, 2012.
Our primary executive offices are located at 1 Great Valley Parkway, Suite 24, Malvern, Pennsylvania 19355 and our
telephone number is (484) 320-2930. Our website address is www.telabio.com. The information contained in, or that can
be accessed through, our website is not part of this Annual Report. We make available, free of charge and through our
website, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any
amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as
reasonably practicable after they are electronically filed with or furnished to the SEC.
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ITEM 1A.
RISK FACTORS
You should carefully consider the following risks described below, together with all of the other information in this Annual
Report, including our consolidated financial statements and related notes. While we believe that the risks and uncertainties
described below are the material risks facing our business, additional risks that we do not know of or that we currently
think are immaterial may also arise and materially affect our business. The realization of any of these risks could have a
material adverse effect on our business, financial condition, results of operations, and our ability to accomplish our
strategic objectives.
Risks Related to Achieving or Sustaining Profitability, Financial Position and Capital Requirements
We have incurred significant operating losses since inception, we expect to incur operating losses in the future, and we
may not be able to achieve or sustain profitability.
We have incurred net losses since our incorporation on April 17, 2012. For the years ended December 31, 2023, 2022 and
2021, we had net losses of $46.7 million, $44.3 million and $33.3 million, respectively. As of December 31, 2023, we had
an accumulated deficit of $320.9 million.
We expect to continue to incur significant sales and marketing, research and clinical development, regulatory and other
expenses as we expand our sales and marketing efforts to increase adoption of our products, expand existing relationships
with our customers, obtain regulatory clearances or approvals for our planned or future products, conduct clinical trials on
our existing and planned or future products, develop, acquire or license complimentary products for our product portfolio,
or add new features to our existing products. As a result, we expect to continue to incur operating losses for the foreseeable
future and may never achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase
profitability on an ongoing basis. If we do not achieve or sustain profitability, it will be more difficult for us to finance our
business and accomplish our strategic objectives, either of which would have a material adverse effect on our business,
financial condition and results of operations and may cause the market price of our common stock to decline.
Our indebtedness may limit our flexibility in operating our business and adversely affect our financial health and
competitive position.
As of December 31, 2023, we had $40.0 million of indebtedness outstanding under our credit facility with MidCap
Financial Trust (“MidCap”) that matures in May 2027.
To service this indebtedness and any additional indebtedness we may incur in the future, we need to generate cash from our
operating activities. Our ability to generate cash is subject, in part, to our ability to successfully execute our business
strategy, as well as general economic, financial, competitive, regulatory, and other factors beyond our control. We cannot
assure you that our business will be able to generate sufficient cash flow from operations or that future borrowings or other
financings will be available to us in an amount sufficient to enable us to service our indebtedness and fund our other
liquidity needs. To the extent we are required to use cash from operations or the proceeds of any future financing to service
our indebtedness, our ability to plan for, or react to, changes in our business, industry and the economy generally will be
limited.
In addition, the MidCap credit facility contains certain covenants that limit our ability to engage in certain transactions that
may be in our long-term best interests, including the incurrence of additional indebtedness, effecting certain corporate
changes, making certain investments, acquisitions or dispositions and paying dividends.
We have not previously breached and are not currently in breach of these or any of the other covenants; however, there can
be no guarantee that we will not breach these covenants in the future. In the event that we breach one or more covenants,
our lender may choose to declare an event of default and require that we immediately repay all amounts outstanding,
terminate any commitment to extend further credit and foreclose on the collateral granted to it to collateralize such
indebtedness. The occurrence of any of these events could have a material adverse effect on our business, financial
condition and results of operations.
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We may require substantial additional capital to finance our planned operations, which may not be available to us on
acceptable terms or at all.
If needed, any future funding requirements will depend on many factors, including:
● surgeon and market acceptance of our products;
● the cost of our research and development activities;
● the cost and timing of obtaining regulatory clearances or approvals;
● the cost and timing of establishing additional sales and marketing capabilities;
● the cost and timing of clinical trials that we are currently conducting or may conduct in the future;
● costs associated with any product recall that may occur;
● the effect of competing products in our markets or competing technologies;
● the extent to which we acquire or invest in products, technologies and businesses, although we currently have
no commitments or agreements relating to any of these types of transactions;
● the cost of filing and prosecuting patent applications and defending and enforcing our patent or other
intellectual property rights; and
● the cost of defending, in litigation or otherwise, any claims that we infringe third-party patents or other
intellectual property rights.
Any additional equity or debt financing that we raise may contain terms that are not favorable to us or our stockholders. In
addition, any future debt financing into which we enter may impose upon us additional covenants that restrict our
operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common
stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. If we raise additional
funds through collaboration and licensing arrangements with third-parties, it may be necessary to relinquish some rights to
our technologies or our products, or grant licenses on terms that are not favorable to us.
Furthermore, we cannot be certain that additional funding will be available on acceptable terms, if at all. If we do not have,
or are not able to obtain, sufficient funds, we may have to delay development or commercialization of our products or
license to third-parties the rights to commercialize products or technologies that we would otherwise seek to
commercialize. We also may have to reduce marketing, customer support or other resources devoted to our products or
cease operations. Any of these factors could harm our business, financial condition and results of operations.
If we are unable to expand, manage and maintain our direct sales and marketing organizations, we may not be able to
generate anticipated revenue.
Building the requisite sales, marketing and distribution capabilities to successfully market and sell our products continues
to be expensive and time-consuming and requires significant attention from our leadership team to manage. Any failure or
delay in the expansion of our sales, marketing or distribution capabilities would adversely impact the commercialization of
our products. Additionally, we may choose to collaborate, either globally or on a territory-by-territory basis, with third
parties on the commercialization of our products. If we are unable to enter into such arrangements on acceptable terms or at
all, we may not be able to successfully commercialize our products.
As of December 31, 2023, our commercial organization consisted of 166 employees in the U.S. and 14 employees in
Europe. To generate future revenue growth, we plan to expand the size and geographic scope of our direct sales
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organization. This growth may require us to split or adjust existing sales territories, which may adversely affect our ability
to retain customers in those territories. Additionally, our future success will depend largely on our ability to continue to
hire, train, retain and motivate skilled sales and marketing personnel with significant industry experience and technical
knowledge of medical devices and related products. The competition for talented individuals experienced in selling and
marketing medical device products is intense, and we cannot assure you that we can assemble or maintain an effective
team. We cannot assure you that we will be able to hire and retain additional personnel on favorable or commercially
reasonable terms, if at all. Our operating results are directly dependent upon the sales and marketing efforts of our
employees. Failure to hire or retain qualified sales and marketing personnel would prevent us from expanding our business
and generating revenue. If we are unable to expand our sales and marketing capabilities, we may not be able to effectively
commercialize our products, which could have an adverse effect on our business, financial condition and results of
operations.
Macroeconomic conditions, including the lingering economic effects of the COVID-19 pandemic on hospital systems,
may negatively impact certain aspects of our business, our prospects, results of operations and financial condition.
Macroeconomic conditions, including the lingering economic effects of the COVID-19 pandemic, have negatively
impacted our business, results of operations and financial condition, and, if unresolved or exacerbated by inflationary
pressures, geopolitical conflict or other macroeconomic events, may adversely impact our business, financial condition and
prospects. While the direct impact of COVID-19 and its variants has largely subsided, we cannot predict the severity of any
long-term impact stemming from financial and resource strains on the healthcare system, labor and staffing in the hospital
sector, and hospital capacity for elective procedures, that resulted from measures taken to address the COVID-19
pandemic. Any prolonged delays in normalized levels of elective surgeries by governmental, hospital or payor actions
would continue to impair net sales of our products.
General supply chain disruptions, initially arising from COVID-19, have in the wake of geopolitical turmoil, such as the
ongoing Russia-Ukraine conflict and the current conflict in Israel and Gaza (including any escalation or expansion)
continued to threaten trade globally and weaken supply systems. We currently rely on Aroa, which is headquartered in New
Zealand, for supply of our products. While there have been minimal disruptions to our supply chain to date, there is a risk
that in the future supplies of our products could be disrupted or delayed based on competition within the supply chain or
otherwise affected by substantial inflationary pressures due to macroeconomic conditions. There can be no assurance that
we would be able to timely implement any mitigation plans relating to our supply chain.
Continued concerns about the systemic impact of potential economic slowdown or recession, liquidity constraints, failures
and instability in the U.S. and international financial banking systems, and geopolitical turmoil, including the ongoing
Russia-Ukraine conflict and the current conflict in Israel and Gaza (including any escalation or expansion), have
contributed to increased market volatility and diminished expectations for economic growth in the world. These conditions
may lead to continued volatility in the future, which could result in a decline in our stock price, high inflation, increase our
cost of capital and adversely affect our ability to access the capital markets in the future even after local conditions
improve.
Market acceptance of our medical products in the U.S. and other countries is dependent upon the procurement practices of
our customers, patient need for our products and procedures and the reimbursement of patients’ medical expenses by
government healthcare programs and third-party payors. The continuing uncertainty surrounding global economic
conditions and financial markets, including the lingering economic impact of the COVID-19 pandemic on our customers,
may adversely affect demand for our products and procedures and result in lower reimbursement rates or coverage for our
products, resulting in lower sales volume and downward pricing pressure on our products and slower adoption of new
products.
The full extent to which these macroeconomic factors, will further, directly or indirectly, impact our business, results of
operations and financial condition, including our sales, expenses, manufacturing capability, supply chain integrity, research
and development activities, and employee-related matters, will depend on future developments that are highly uncertain.
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Information pertaining to the impact of these macroeconomic pressures on our operations to date can be found in
“Management's Discussion and Analysis of Financial Position and Results of Operations” in this Annual Report on Form
10-K.
Rising inflation rates could negatively impact our revenues and profitability if increases in the prices of our product or
a decrease in consumer spending results in lower volumes of elective surgeries. In addition, if our costs increase and
we are not able to pass along these price increases, our profitability would be adversely affected, and the adverse impact
may be material.
Inflation rates, particularly in the U.S., have increased recently to levels not seen in years. Increased inflation may result in
decreased demand for our products, increased operating costs (including our labor costs), reduced liquidity, and limitations
on our ability to access credit or otherwise raise debt and equity capital. In addition, the United States Federal Reserve has
raised, and may in the future raise, interest rates in response to concerns about inflation. Increases in interest rates,
especially if coupled with reduced government spending and volatility in financial markets, may have the effect of further
increasing economic uncertainty and heightening these risks. In an inflationary environment, we may be unable to raise the
prices of our products at or above the rate at which our costs increase, which could/would reduce our profit margins and
have a material adverse effect on our financial results. We also may experience lower than expected sales and potential
adverse impacts on our competitive position if there is a decrease in consumer spending or a negative reaction to our
pricing. A reduction in our revenue would be detrimental to our profitability and financial condition and could also have an
adverse impact on our future growth.
Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity,
defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current
and projected business operations and financial condition and results of operations.
Events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial
institutions, transactional counterparties or other companies in the financial services industry or the financial services
industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in
the future lead to market-wide liquidity problems. For example, in early 2023, several financial institutions closed and were
taken into receivership by the Federal Deposit Insurance Corporation. Even though we assess our banking and customer
relationships as we believe necessary or appropriate, our access to funding sources and other credit arrangements in
amounts adequate to finance or capitalize our current and projected future business operations could be significantly
impaired by factors that affect us, the financial services industry or economy in general. These factors could include,
among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of
financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or
financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry.
In addition, investor concerns regarding the U.S. or international financial systems could result in less favorable
commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or
systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing
on acceptable terms or at all. Any decline in available funding or access to our cash and liquidity resources could, among
other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other
obligations, result in breaches of our contractual obligations or result in violations of federal or state wage and hour laws.
Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not
described above, could have material adverse impacts on our liquidity and our business, financial condition or results of
operations.
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Risks Related to the Commercialization of our Products
To date, the vast majority of our revenue has been generated from sales of our OviTex products, and we therefore are
highly dependent on the commercial success of the OviTex product line.
Sales of our OviTex products accounted for 67%, 70% and 78% of total revenue for the years ended December 31, 2023,
2022 and 2021, respectively. We first commercialized OviTex products in the U.S. in 2016 and have subsequently launched
our OviTex products in Europe, introduced our larger sized OviTex products, our OviTex LPR product for use in
laparoscopic and robotic-assisted hernia surgical repairs and larger configurations of our LPR product. In addition to our
OviTex products, we have also commercialized our OviTex PRS products for use in surgery for soft-tissue repair or
reinforcement in plastic and reconstructive procedures and most recently the LiquiFix Hernia Mesh Fixation Devices
(LiquiFix FIX8™ and LiquiFix Precision™) pursuant to our distribution agreement with Advanced Medical Solutions
Limited. While we continue to diversify our portfolio and revenue sources, we expect that sales of our OviTex products and
our OviTex PRS products will account for the majority of our revenue for the foreseeable future while we continue to grow
market share for our OviTex PRS products and other ancillary products that we may develop or distribute from time to
time. Our failure to successfully increase sales of these products or any other event impeding our ability to sell these
products would result in a material adverse effect on our business, financial condition and results of operations.
The commercial success of our products will largely depend upon attaining significant market acceptance.
Our ability to execute our growth strategy, achieve commercial success and become profitable will depend upon the
adoption by inpatient and outpatient hospitals, surgeons, and medical device supply chain participants of our reinforced
tissue matrix products. We cannot predict how quickly, if at all, surgeons will accept our products or, if accepted, how
frequently they will be used. Our products and planned or future products we may develop or market may never gain broad
market acceptance among surgeons and the medical community for some or all of our indications. Some surgeons may
have prior history with or a preference for other soft-tissue reinforcement products, such as permanent synthetic mesh,
resorbable synthetic mesh, or other biologic matrices, or may be reluctant to alter their practice patterns to treat patients
with our reinforced tissue matrix products. The degree of market acceptance of any of our products will depend on a
number of factors, including:
● whether surgeons and others in the medical community consider our products to be safe, effective and cost
effective;
● the potential and perceived advantages of our products over alternative products;
● the effectiveness of our sales and marketing efforts for our products;
● the prevalence and severity of any complications associated with using our products;
● the convenience and ease of use of our products relative to competing products;
● product labeling or product insert requirements by regulatory authorities;
● the competitive pricing of our products;
● the quality of our products meeting patient and surgeon expectations;
● the results of clinical trials and post-market clinical studies relating to the use of our products;
● pricing pressure, including from GPOs and government payors;
● the availability of coverage and adequate reimbursement for procedures using our products from third-party
payors, including government authorities;
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● the willingness of patients to pay out-of-pocket for our products in the absence of coverage and adequate
reimbursement by third-party payors, including government authorities; and
● our ability to provide incremental clinical and economic data that show the safety, clinical efficacy and cost
effectiveness, and patient benefits from, our products.
Additionally, even if our products achieve market acceptance, they may not maintain that market acceptance over time if
competing products or technologies, which are more cost effective or received more favorably, are introduced. Failure to
achieve or maintain market acceptance and/or market share would limit our ability to generate revenue and would have a
material adverse effect on our business, financial condition and results of operations.
Even if we are able to attain significant market acceptance of our products, the commercial success of our products is
not guaranteed.
Our future financial success will depend substantially on our ability to effectively and profitably market and sell our
products. Even if we are able to attain significant market acceptance of our products, the commercial success of our
products and any of our planned or future products is dependent on a number of additional factors, including the results of
clinical trials relating to the use of our products and our ability to obtain and maintain regulatory approval or clearance to
market our products and maintain compliance with applicable regulatory requirements. Successful growth of our sales and
marketing efforts will depend on the strength of our marketing and distribution infrastructure and the effectiveness of our
marketing and sales efforts, including our efforts to expand our direct sales force, while our ability to satisfy demand for
our products driven by our sales and marketing efforts will be largely dependent on the ability of Aroa to maintain a
commercially viable manufacturing process that is compliant with regulatory standards. If we fail to successfully market
and sell our products, we will not be able to achieve profitability, which will have a material adverse effect on our business,
financial condition and results of operations.
Our ability to grow our revenue in future periods will depend on our ability to increase sales of our OviTex and OviTex
PRS products and any new product or product indications that we introduce, which will, in turn, depend in part on our
success in expanding our customer base and driving increased use of our products. New products or product indications
may also need to be approved or cleared by the FDA and comparable non-U.S. regulatory agencies to drive revenue
growth. If we cannot achieve revenue growth, it could have a material adverse effect on our business, financial condition
and results of operations.
The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to
product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have
engaged in the promotion of our products for these uses.
Surgeons and other medical professionals may misuse our reinforced tissue matrix products or use improper techniques if
they are not adequately trained, potentially leading to injury and an increased risk of product liability. If our products are
misused or used with improper technique, we may become subject to costly litigation by our customers or their patients.
Product liability claims could divert management’s attention from our core business, be expensive to defend and result in
sizeable damage awards against us that may not be covered by insurance. In addition, any of the events described above
could harm our business.
The products we commercialize have been cleared by the FDA and other regulatory authorities for specific indications. Our
OviTex products are reinforced tissue matrices designed for use as a surgical mesh to reinforce and/or repair soft-tissue
where weakness exists and indications for use of our OviTex products include the repair of hernia and/or abdominal wall
defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. Our OviTex PRS
products are reconstructive reinforced tissue matrices designed for implantation to reinforce soft-tissue where weakness
exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. In connection with the
March 2019 meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, the
FDA stated that no surgical mesh device has been cleared or approved for use in breast surgery, and that to obtain such
indication, the product sponsor must obtain an approved PMA. This statement applies to our OviTex PRS products as they
are not cleared or approved for use in breast surgery and thus, we are prohibited from
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marketing them for that use. OviTex PRS or any other product we may develop for use in breast surgery will need to be
approved specifically for that indication and there can be no guarantee that it will be approved. We have engaged in
discussions with the FDA regarding an IDE protocol to study the safety and effectiveness of our OviTex PRS product for
an indication in breast reconstruction surgery. There can be no assurance that we will be able to secure a PMA approval in
a timely manner, or at all. Any marketing for OviTex PRS or any other product for a use in breast reconstruction surgery
would be deemed off-label promotion of that product if it has been cleared for a general indication of use to reinforce or
repair soft-tissue and has not received an approval specifically for use in breast surgery. We train our marketing personnel
and direct sales force to not promote our OviTex or OviTex PRS products for uses outside of the FDA-cleared indications
for use, known as “off-label uses.” We cannot, however, prevent a surgeon or medical professional from using our OviTex
or OviTex PRS products or other products we may commercialize in the future for off-label uses.
Although we train our direct sales force not to promote our products for off-label uses, and our instructions for use in all
markets specify that our products are not intended for use outside of those indications cleared or approved for use, the FDA
or another regulatory authority could conclude that we have engaged in off-label promotion. If the FDA determines that our
promotional or training materials constitute promotion of an off-label use, or make claims that are not supported by the
available clinical data, it could request that we modify our training or promotional materials or subject us to regulatory or
enforcement actions. It is also possible that other federal, state or non-U.S. enforcement authorities might take action under
other regulatory authority if they consider our business activities to constitute promotion of an off-label use, or are
otherwise objectionable, which could result in significant penalties, including, but not limited to, criminal, civil and
administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs
and the curtailment of our operations.
Even if surgeons or medical professionals use our OviTex and OviTex PRS products only for their approved indications, a
failure by such surgeons and medical professionals to use our products in accordance with the processes and procedures
established to properly utilize our OviTex and OviTex PRS products could result in product liability lawsuits, costly
investigations and potentially affect our ability to achieve sufficient market penetration for our OviTex and OviTex PRS
products. In those possible events, our reputation could be damaged and adoption of the products would be impaired. We
may also be required to reassess the training, written instructions and product warnings or other labeling information we
provide our customers. This process could require us to expend significant time and capital and could have a material
adverse effect on our business, financial condition and results of operations and impair our ability to grow our business.
If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our OviTex, OviTex PRS or
other products we may commercialize in the future, our commercial success may be hindered.
Our ability to successfully commercialize and achieve market acceptance of our products depends, in significant part, on
the availability of adequate financial coverage and reimbursement from third-party payors, including governmental payors
(such as the Medicare and Medicaid programs in the U.S.), managed care organizations and private health insurers. The
primary customers for our products are hospitals and ambulatory surgery centers who will then seek reimbursement from
third-party payors for the procedures performed using our products. While some third-party payors currently cover and
provide reimbursement for procedures using our currently cleared or approved products, we can give no assurance that
these third-party payors will continue to provide coverage and adequate reimbursement for the procedures using our
products, to permit hospitals and surgeons to offer procedures using our products to patients requiring treatment, or that
current reimbursement levels for procedures using our products will continue. Additionally, no uniform policy for coverage
and reimbursement exists in the U.S. and coverage and reimbursement can differ significantly from payor to payor. If third-
party payors reverse or limit their coverage for the procedures using our currently cleared or approved products in the
future, this could have a material adverse effect on our business. If we are forced to lower the price we charge for our
products, this could have a material adverse effect on our business, financial condition and results of operations and impair
our ability to grow our business. See the section of this Annual Report titled “Coverage and Reimbursement” for more
information.
Healthcare costs have risen significantly over the past decade, which has resulted in or led to numerous cost reform
initiatives. Third-party payors, whether U.S. or non-U.S., or governmental or commercial, are developing increasingly
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sophisticated methods of controlling healthcare costs, including examining the cost effectiveness of procedures, in addition
to their safety and efficacy, when making coverage and payment decisions. Payors continually review new and existing
technologies for possible coverage and can, without notice, deny or reverse coverage or alter pre-authorization
requirements for new or existing procedures. We cannot provide assurance that we will be successful in any efforts we may
potentially undertake to reverse such non-coverage decisions. If we are not successful in reversing non-coverage policies,
or if third-party payors that currently cover or reimburse certain procedures reverse or limit their coverage of such
procedures in the future, or if other third-party payors issue similar policies, our business could be adversely impacted.
Our long-term growth may depend on our ability to enhance our product offerings.
It is important to our business that we continue to enhance our OviTex and OviTex PRS products and develop and
introduce new reinforced tissue matrix products. Developing products is expensive and time-consuming and could divert
management’s attention away from other aspects of our business. The success of any new reinforced tissue matrix product
offering or product enhancements to our OviTex and OviTex PRS products will depend on several factors, including our
ability to:
● properly identify and anticipate surgeon and patient needs;
● develop and introduce new products and product enhancements in a timely manner;
● avoid infringing upon the intellectual property rights of third parties;
● ensure the quality, manufacture and supply of new products by Aroa;
● demonstrate, if required, the safety and efficacy of new products with data from preclinical studies, clinical
trials and post-market clinical studies;
● obtain the necessary regulatory clearances or approvals for expanded indications, new products or product
modifications;
● be fully FDA-compliant with marketing of new devices or products;
● provide adequate training to potential users of our new products;
● receive adequate coverage and reimbursement for procedures performed with our new products; and
● develop and expand an effective and dedicated sales and marketing team.
If we are not successful in introducing new product indications and developing and commercializing new products and
product enhancements, our ability to increase our revenue may be impaired, which could have a material adverse effect on
our business, financial condition and results of operations.
In the future our products may become obsolete, which would negatively affect operations and financial condition.
The medical device industry is characterized by rapid and significant change. There can be no assurance that other
companies will not succeed in developing or marketing devices and products that are more effective than our reinforced
tissue matrix products or that would render our reinforced tissue matrix products obsolete or noncompetitive. Additionally,
new surgical procedures, medications and other therapies could be developed that replace or reduce the importance of our
products. Accordingly, our success will depend in part on our ability to respond quickly to medical and other changes
through the development and introduction of new products. Our reinforced tissue matrix products have a limited shelf life
and will expire if not timely used. Product development involves a high degree of risk, and there can be no assurance that
our new product development efforts will result in any commercially successful products.
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To successfully market and sell our products in markets outside of the U.S., we must address many international
business risks with which we have limited experience.
Approximately 10%, 8% and 5% of our revenue for the years ended December 31, 2023, 2022 and 2021, respectively,
came from sales in markets outside of the U.S. Part of our sales strategy is to maintain our European presence. European
sales are subject to a number of risks, including:
● difficulties in staffing and managing international operations;
● increased competition as a result of more products and procedures receiving regulatory approval in
international markets;
● longer accounts receivable payment cycles and difficulties in collecting accounts receivable;
● fluctuations in currency exchange rates;
● non-U.S. certification and regulatory clearance or approval requirements;
● difficulties in developing effective marketing campaigns in unfamiliar countries;
● customs clearance and shipping delays;
● complexities associated with managing multiple payor reimbursement regimes, government payors or patient
self-pay systems;
● political, social, and economic instability abroad, terrorist attacks, and security concerns in general;
● the impact of the macroeconomic factors, including pandemics, epidemics and other public health outbreaks,
inflationary pressures and geopolitical conflicts, such as the ongoing Russia-Ukraine conflict and the current
conflict in Israel and Gaza (including any escalation or expansion);
● natural disasters and pandemics, epidemics or public health outbreaks, which result in lock-downs, travel
restrictions and other restrictions on our ability to operate internationally;
● preference for locally produced products;
● potentially adverse tax consequences, including the complexities of non-U.S. value-added tax systems, tax
inefficiencies related to our corporate structure, and restrictions on the repatriation of earnings;
● the burdens of complying with a wide variety of non-U.S. laws and different legal standards; and
● increased financial accounting and reporting burdens and complexities.
If one or more of these risks are realized, our business, financial condition and results of operations could be adversely
affected.
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Risks Related to Our Reliance on Third Parties
We are highly dependent upon Aroa, as the exclusive manufacturer and supplier of our OviTex and OviTex PRS
products.
In August 2012, we entered into our Aroa License which was amended and restated in July 2015. The Aroa License grants
us an exclusive license in North America, the EU, United Kingdom, Norway, Switzerland, Russia and former Soviet
satellite countries to certain intellectual property rights, including patents relating to the use of bovine and ovine rumen as a
source of extracellular matrix. Under the Aroa License, Aroa is our exclusive manufacturer and supplier of our OviTex and
OviTex PRS products.
We are reliant upon the intellectual property we license from Aroa for the development and commercialization of our
products. Under the Aroa License, we hold an exclusive license to certain intellectual and technology rights to develop,
commercialize and sell certain endoform regenerative template products derived from cows and sheep. The Aroa License
also provides for cooperative development of our products utilizing the licensed intellectual property and all of our
products rely on intellectual property owned by Aroa and licensed to us under the Aroa License. The Aroa License imposes
various developmental and regulatory requirements upon us along with requiring us to make milestone payments upon the
achievement of certain commercial and regulatory milestones. If we fail to comply with our obligations under the Aroa
License, Aroa will have the right to terminate the Aroa License, in which event we would not be able to develop and
market our products.
Aroa is required under the Aroa License to manufacture all of our OviTex and OviTex PRS products at its manufacturing
and warehousing facility in Auckland, New Zealand. The production of all of our OviTex and OviTex PRS products in a
single location exposes us to the risk of Aroa’s facility being harmed or rendered inoperable by natural or man-made
disasters or pandemics, which may render it difficult or impossible for Aroa to perform its manufacturing and assembly
activities for some time. Although we and Aroa intend to establish redundant production facilities to lessen the risk of
production disruptions, we will need to ensure that any manufacturing facility complies with our quality expectations and
applicable regulatory requirements. If we are unable to establish redundant manufacturing facilities in a timely manner, any
disruption in the manufacture of our OviTex and OviTex PRS products at Aroa’s manufacturing and warehouse facility, the
continued commercialization of our OviTex and OviTex PRS products, the supply of our OviTex and OviTex PRS products
to customers and the development of any new reinforced tissue matrix products will be delayed, limited or prevented,
which could have material adverse effect on our business, financial condition and results of operations.
Under the Aroa License, Aroa is responsible for supplying all of the raw materials and components used in the manufacture
and assembly of our OviTex and OviTex PRS products. If Aroa is unable to supply the raw materials and components or to
manufacture and assemble our OviTex and OviTex PRS products reliably and at the levels we anticipate or that are
required by the market, we may be unable to acquire a substitute supply of raw materials and components on a timely
basis, if at all.
Under the Aroa License Aroa also holds the FDA clearances under which we commercialize our OviTex and OviTex LPR
products, and maintains ultimate responsibility for all regulatory interactions with FDA relating to our OviTex producst,
including OviTex LPR and decisions made with respect to changing or updating those clearances. If Aroa fails to comply
with all applicable regulatory requirements and maintain the FDA clearances related to our OviTex products, we may be
unable to commercialize our OviTex products on a timely basis, or at all. Our ability to supply our OviTex and OviTex PRS
products commercially and to develop any future products depends, in part, on our ability to obtain these materials,
components and products in accordance with regulatory requirements and in sufficient quantities for commercialization
and clinical testing. While Aroa has historically met our demand for its products and services on a timely basis in the past,
we cannot guarantee that it will always be able to meet our demand for its products. If Aroa fails to meet demand or
notifies us that it believes it will fail to meet demand for our OviTex and OviTex PRS products, we are required under the
Aroa License to work with Aroa to cure its supply failure and may, only in certain circumstances and on a temporary basis,
engage a replacement contract manufacturer to mitigate a failure by Aroa to meet demand for our OviTex and OviTex PRS
products. As such, we are highly dependent upon Aroa’s continued ability to supply our OviTex and OviTex PRS products
at the levels we require and any production shortfall that impairs the supply of our
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OviTex and OviTex PRS products could have a material adverse effect on our business, financial condition and results of
operations and adversely affect our ability to satisfy demand for our OviTex and OviTex PRS products, which could
adversely affect our product sales and operating results materially.
We, or our partners, may experience development or manufacturing problems, capacity constraints, or delays in the
production of our products that could limit the potential growth of our revenue or increase our losses.
We may encounter unforeseen situations in Aroa’s manufacturing and assembly of our OviTex and OviTex PRS products
that would result in delays or shortfalls in its production. For example, Aroa was unable to supply us with our products
from September 2017 to December 2017 due to a quality testing process failure identified by Aroa. Personnel shortages
and reduced manufacturing capacity due to the COVID-19 pandemic may also result in a disruption in production.
Based upon our current planned market adoption we believe we will reach our capacity limitations in the Aroa facility.
Aroa expanded its manufacturing capacity, with approximately 15,000 square feet of additional manufacturing space being
constructed in a neighboring facility, in 2022. If we are unable to successfully expand capacity, we may not be able to meet
the demand for our products. In addition, Aroa’s production processes and assembly methods may have to change in order
to accommodate any significant future expansion of its manufacturing capacity, which may increase our manufacturing
costs, delay production of our products and adversely impact our business. Conversely, if demand for our OviTex and
OviTex PRS products shifts such that Aroa’s manufacturing facility is operated below its capacity for an extended period, it
may adjust its manufacturing operations to reduce fixed costs, which could lead to uncertainty and delays in manufacturing
times and quality during any transition period.
If Aroa’s manufacturing activities are adversely impacted or if it is otherwise unable to keep up with demand for our
OviTex and OviTex PRS products by successfully manufacturing, assembling, testing and shipping our OviTex and OviTex
PRS products in a timely manner, our revenue could be impaired, market acceptance for our products could be adversely
affected and our customers might instead purchase our competitors’ products, which would have a material adverse effect
on our business, financial condition and results of operations.
Our products contain materials derived from animal sources and may become subject to additional regulation.
Our products are manufactured using ovine rumen. Products that contain materials derived from animal sources are
increasingly subject to scrutiny in the media and by regulatory authorities. Regulatory authorities are concerned about the
potential for the transmission of disease, particularly progressive neurodegenerative disorders, from animals to humans via
those materials. In addition, the COVID-19 pandemic heightened public awareness of animals and animal products as a
disease vector. Products that contain materials derived from animals, including our products, may become subject to
additional regulation, or even be banned in certain countries, because of concern over the potential for the transmission of
infectious agents. Significant new regulation, or a ban of our products, could impair our current business or our ability to
expand our business, and in the case of a ban or suspension, could have a material adverse effect on our business, financial
condition and results of operations.
Our supply of ovine rumen for use in manufacturing our products may be vulnerable to disruption due to natural
disaster, disease or other events.
The ovine rumen used in the manufacturing of our products is sourced through Aroa in New Zealand. Although Aroa
obtains its supply of ovine rumen from jurisdictions with sheep that are not currently known to carry any prion disease
(progressive neurodegenerative disorders, including scrapie disease), there can be no assurance that these flocks will
remain prion disease-free or that a future outbreak or presence of other unintended and potentially hazardous agents would
not adversely affect our products or patients that may receive them. The geographic concentration of our supply chain
increases our vulnerability to disruption due to natural disasters, disease or other events. If there is a disruption in the
supply of ovine rumen to our manufacturer and supplier, we may be unable to fulfill customer orders or delay the
commercialization of new products.
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We may also be prohibited from importing our products into the U.S. in the event of disease outbreak or other event
impacting the sheep population in New Zealand. Any disruption in our supply lines could have a material adverse effect on
our business, financial condition and results of operations.
Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business
and harm our reputation and ability to provide our products on a timely basis.
Expedited, reliable shipping is essential to our operations. We rely heavily on providers of transport services for reliable
and secure point-to-point transport of our OviTex portfolio products (and would rely heavily on such providers for any
other products we may commercialize and ship in the future) to our customers and for tracking of these shipments. Should
a carrier encounter delivery performance issues such as loss, damage or destruction of any of our products, it would be
costly to replace such products in a timely manner and such occurrences may damage our reputation and lead to decreased
demand for our OviTex portfolio products (or any other products we commercialize in the future) and increased cost and
expense to our business. In addition, any significant increase in shipping rates could adversely affect our operating margins
and results of operations. Similarly, strikes, severe weather, natural disasters, disease or other service interruptions affecting
delivery services we use would adversely affect our ability to deliver our OviTex and OviTex PRS products (or any other
products we commercialize in the future) on a timely basis. For example, disruptions to transportation infrastructure as a
result of macroeconomic conditions may impact our ability to provide our products to our customers.
Risks Related to Intellectual Property Matters
We may need to license intellectual property from third parties, and such licenses may not be available or may not be
available on commercially reasonable terms.
We may need to obtain licenses from third parties to advance our research or allow commercialization of our products, and
we cannot provide any assurances that third-party patents do not exist which might be enforced against our products in the
absence of such a license. The licensing and acquisition of third-party intellectual property rights is a competitive practice
and companies that may be more established, or have greater resources than we do, may also be pursuing strategies to
license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to
commercialize our products. We may fail to obtain any of these licenses on commercially reasonable terms, if at all. Even
if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies
licensed to us. In that event, we may be required to expend significant time and resources to develop or license replacement
technology. If we are unable to do so, we may be unable to develop or commercialize the affected products, which could
materially harm our business and the third parties owning such intellectual property rights could seek either an injunction
prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of
compensation. Licensing of intellectual property is of critical importance to our business and involves complex legal,
business and scientific issues. If disputes over intellectual property that we have licensed prevent or impair our ability to
maintain our current licensing arrangements on acceptable terms, we may not be able to successfully develop and
commercialize the affected products, which would have a material adverse effect on our business.
If we fail to comply with our obligations under any license, collaboration or other agreements, we could lose intellectual
property rights that are necessary for developing and protecting our products.
We have licensed certain intellectual property rights covering our current products from third parties, including Aroa. We
are heavily dependent on our agreements with such third parties for our current products. If, for any reason, one or more of
our agreements is terminated or we otherwise lose those rights, it could harm our business. Our license and other
agreements impose, and any future collaboration agreements or license agreements we enter into are likely to impose
various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution
and enforcement or other obligations on us. If we breach any material obligations, or use the intellectual property licensed
to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the
license, which could result in us being unable to develop, manufacture and sell products that are
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covered by the licensed technology, having to negotiate new or reinstated licenses on less favorable terms, or enabling a
competitor to gain access to the licensed technology.
If we are unable to adequately protect our intellectual property rights, or if we are accused of infringing on the
intellectual property rights of others, our competitive position could be harmed or we could be required to incur
significant expenses to enforce or defend our rights.
Our commercial success will depend in part on our success in obtaining and maintaining issued patents, trademarks and
other intellectual property rights in the U.S. and elsewhere and protecting our proprietary technology. If we do not
adequately protect our intellectual property and proprietary technology, competitors may be able to use our technologies or
the goodwill we have acquired in the marketplace and erode or negate any competitive advantage we may have, which
could harm our business and ability to achieve profitability.
We own seventeen issued or allowed U.S. patents and have sixteen pending U.S. patent applications. As of December 31,
2023, we had rights, whether through ownership or licensing, to nineteen issued or allowed U.S. patents, sixteen pending
U.S. patent applications, five issued non-U.S. patents and three pending non-U.S. patent applications. Our issued U.S.
patents will expire between 2035 and 2041. The licensed patents will expire between 2029 and 2031.
Our ability to enforce our patent rights depends on our ability to detect infringement. It may be difficult to detect infringers
who do not advertise the components that are used in their products. Moreover, it may be difficult or impossible to obtain
evidence of infringement in a competitor’s or potential competitor’s product. We may not prevail in any lawsuits that we
initiate and the damages or other remedies awarded if we were to prevail may not be commercially meaningful.
The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all
necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to
identify patentable aspects of our research and development output before it is too late to obtain patent protection. We
cannot provide any assurances that any of our patents, or patents to which we have ownership rights through licensing
agreements, have, or that any of our pending patent applications that mature into issued patents will include, claims with a
scope sufficient to protect our OviTex and OviTex PRS products, any additional features we develop for our OviTex and
OviTex PRS products or any new products we seek to develop in the future. Other parties may have developed
technologies that may be related or competitive to our OviTex and OviTex PRS products, may have filed or may file patent
applications and may have received or may receive patents that overlap or conflict with our patent applications, either by
claiming the same methods or devices or by claiming subject matter that could dominate our patent position. The patent
positions of medical device companies, including our patent position, may involve complex legal, scientific and factual
questions, and, therefore, the issuance, scope, validity and enforceability of any patent claims that we may obtain cannot be
predicted with certainty. Patents, if issued, may be challenged, deemed unenforceable, invalidated or circumvented.
Proceedings challenging our patents could result in either loss of the patent or denial of the patent application or loss or
reduction in the scope of one or more of the claims of the patent or patent application. In addition, such proceedings may
be costly. Thus, any patents that we may own, or to which we have ownership rights through licensing agreements, may not
provide any protection against competitors. Furthermore, an adverse decision in a judicial or administrative proceeding can
result in a third party receiving the patent right sought by us, which in turn could affect our ability to commercialize our
products.
Patents covering our products could be found invalid or unenforceable if challenged in court or before administrative
bodies in the U.S. or abroad.
Although an issued patent is presumed valid and enforceable, its issuance is not conclusive as to its validity or its
enforceability and it may not provide us with adequate proprietary protection or competitive advantages against
competitors with similar products. Competitors could purchase our OviTex or OviTex PRS products and attempt to
replicate the competitive advantages we derive from our development efforts, willfully infringe our intellectual property
rights, design around the relevant patents, or develop and obtain patent protection for more effective technologies, designs
or methods. We may be unable to prevent the unauthorized disclosure or use of our technical knowledge or trade secrets by
consultants, suppliers, vendors, former employees and current employees. The laws of some non-U.S.
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countries do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant
problems in protecting our proprietary rights in these countries.
In addition, proceedings to enforce or defend our patents, or patents to which we have ownership rights through licensing
agreements, could put those patents at risk of being invalidated, held unenforceable or interpreted narrowly. Such
proceedings could also provoke third parties to assert claims against us, including that some or all of the claims in one or
more of those patents are invalid or otherwise unenforceable. If any of the patents covering our OviTex and OviTex PRS
products are invalidated or found unenforceable, or if a court found that valid, enforceable patents held by third parties
covered one or more of our products, our competitive position could be harmed or we could be required to incur significant
expenses to enforce or defend our rights.
Third parties may assert ownership or commercial rights to inventions we develop.
Third parties may in the future make claims challenging the inventorship or ownership of our intellectual property. In
addition, we may face claims by third parties that our agreements with employees, contractors or consultants obligating
them to assign intellectual property to us are ineffective or in conflict with prior or competing contractual obligations of
assignment, which could result in ownership disputes regarding intellectual property we have developed or will develop
and interfere with our ability to capture the commercial value of such intellectual property. Litigation may be necessary to
resolve an ownership dispute, and if we are not successful, we may be precluded from using certain intellectual property or
may lose our exclusive rights in such intellectual property. Either outcome could harm our business and competitive
position.
Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend
significant time and money, enter into license agreements for disputed intellectual property and could prevent us from
selling our products.
Our commercial success will depend in part on not infringing the patents or violating other proprietary rights of others.
Significant litigation regarding patent rights occurs in our industry. Our competitors may have applied for or obtained, or
may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make, use
and sell our products. We do not always conduct independent reviews of patents issued to third parties. In addition, patent
applications in the U.S. and elsewhere can be pending for many years before issuance, or unintentionally abandoned
patents or applications can be revived, so there may be applications of others now pending or recently revived patents of
which we are unaware. Patent applications in the U.S., the EU and elsewhere are published approximately 18 months after
the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority
date. These applications may later result in issued patents, or the revival of previously abandoned patents, that will prevent,
limit or otherwise interfere with our ability to develop and market our products. Third parties may assert claims that we are
employing their proprietary technology without authorization, including claims from competitors or from nonpracticing
entities that have no relevant product revenue and against whom our own patent portfolio may have no deterrent effect.
As we continue to commercialize our products in their current or updated forms, launch new products and enter new
markets, we expect competitors may claim that one or more of our products infringe their intellectual property rights as a
strategy to impede our commercialization and entry into new markets. The large number of patents, the rapid rate of new
patent applications and issuances, the complexities of the technologies involved, and the uncertainty of litigation may
increase the risk of business resources and management’s attention being diverted to patent litigation. We have received,
and we may in the future receive, letters or other threats or claims from third parties inviting us to take licenses under, or
alleging that we infringe, their patents.
Moreover, we may become party to adversarial proceedings regarding our or third-party patent portfolios. Such
proceedings could include supplemental examination or contested post-grant proceedings such as review, reexamination,
inter partes review, interference or derivation proceedings before the U.S. Patent and Trademark Office (“USPTO”) and
challenges in U.S. District Courts. Patents may be subjected to opposition, post-grant review or comparable proceedings
lodged in various foreign, both national and regional, patent offices. The legal threshold for initiating litigation or contested
proceedings may be low, so that even lawsuits or proceedings with a low probability of success might be
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initiated. Litigation and contested proceedings can also be expensive and time-consuming, and our adversaries in these
proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can.
We may also occasionally use these proceedings to challenge the patent rights of others. We cannot be certain that any
particular challenge will be successful in limiting or eliminating the challenged patent rights of the third party.
Any lawsuits resulting from such allegations could subject us to significant liability for damages and/ or invalidate our
proprietary rights. Any potential intellectual property litigation also could force us to do one or more of the following:
● stop making, selling or using products or technologies that allegedly infringe the asserted intellectual
property;
● lose the opportunity to license our technology to others or to collect royalty payments;
● incur significant legal expenses, including, in some cases, the attorney’s fees and costs of litigation to the
party whose intellectual property rights we may be found to be infringing;
● pay substantial damages (possibly treble damages) or royalties to the party whose intellectual property rights
on which we may be found to be infringing;
● redesign products that contain the allegedly infringing intellectual property; and
● attempt to obtain a license to the relevant intellectual property from third parties, which may not be available
on reasonable terms or at all.
Any litigation or claim against us, even those without merit, may cause us to incur substantial costs, and could place a
significant strain on our financial resources, divert the attention of management from our business and harm our reputation.
If we are found to infringe the intellectual property rights of third parties, we could be required to pay substantial damages
(which may be increased up to three times of awarded damages) and/or substantial royalties and could be prevented from
selling our products unless we obtain a license or are able to redesign our products to avoid infringement. In addition, we
may choose to seek, or be required to seek, a license from a third party, which may not be available on acceptable terms, if
at all. Even if a license can be obtained on acceptable terms, the rights may be non-exclusive, which could give any
competitors access to the same technology or intellectual property rights license to us. Any such license may not be
available on reasonable terms, if at all, and there can be no assurance that we would be able to redesign our products in a
technically feasible way that would not infringe the intellectual property rights of others. We could encounter delays in
product introductions while we attempt to develop alternative methods or products. If we fail to obtain a required license,
the holders of any such patents may be able to block us, our licenses or our collaborators from marketing products based on
the disputed technology until such patents expire, which could limit our ability to generate revenue or achieve profitability
and possibly prevent us from generating revenue sufficient to sustain our operations.
Even if we were ultimately to prevail, any of these events could require us to divert substantial financial and management
resources that we would otherwise be able to devote to our business. Intellectual property litigation, regardless of its
outcome, may cause negative publicity, adversely impact prospective customers, cause product shipment delays, or prohibit
us from manufacturing, importing, marketing or otherwise commercializing our products, services and technology. In
addition, if the breadth or strength of protection provided the patents and patent applications we own or in-license is
threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future
products. In addition, because of the substantial amount of discovery required in connection with intellectual property
litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of
litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or
developments, and if securities analysts or investors view these announcements in a negative light, the price of our
common stock could be adversely affected.
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In addition, we generally indemnify our customers with respect to infringement by our products of the proprietary rights of
third parties. Third parties may assert infringement claims against our customers. These claims may require us to initiate or
defend protracted and costly litigation on behalf of our customers, regardless of the merits of these claims. If any of these
claims succeed or settle, we may be forced to pay damages or settlement payments on behalf of our customers or may be
required to obtain licenses for the products they use. If we cannot obtain all necessary licenses on commercially reasonable
terms, our customers may be forced to stop using our products.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be
harmed.
We also rely upon copyright and trade secret protection, as well as non-disclosure agreements and invention assignment
agreements with our employees, consultants and third parties, to protect our confidential and proprietary information.
In addition to contractual measures, we try to protect the confidential nature of our proprietary information using
commonly accepted physical and technological security measures. Such measures may not provide adequate protection for
our proprietary information. Our security measures may not prevent an employee or consultant from misappropriating our
trade secrets and providing them to a competitor, and recourse we take against such misconduct may not provide an
adequate remedy to protect our interests fully. Unauthorized parties may also attempt to copy or reverse engineer certain
aspects of our products that we consider proprietary. Enforcing a claim that a party illegally disclosed or misappropriated a
trade secret can be difficult, expensive and time-consuming, and the outcome of any such claim is unpredictable. Trade
secret violations are often a matter of state law, and the criteria for protection of trade secrets can vary among different
jurisdictions. In addition, trade secrets may be independently developed or reverse engineered by others in a manner that
could prevent legal recourse by us. If any of our confidential or proprietary information, such as our trade secrets, were to
be disclosed or misappropriated, or if any such information was independently developed by a competitor, our business and
competitive position could be harmed.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in
our markets of interest.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our
target markets and our business may be adversely affected. At times, competitors may adopt trade names or trademarks
similar to ours, thereby impeding our ability to build brand identity, possibly leading to market confusion and potentially
requiring us to pursue legal action. In addition, there could be potential trade name or trademark infringement claims
brought by owners of other registered trademarks or trademarks that incorporate variations of our unregistered trademarks
or trade names. If we are unable to successfully register our trademarks and trade names and establish name recognition
based on our trademarks and trade names, then we may not be able to compete effectively and our business may be
adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain
names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of
resources and could adversely impact our financial condition or results of operations.
We may be unable to enforce our intellectual property rights throughout the world.
Filing, prosecuting and defending patents covering our products in all countries throughout the world would be
prohibitively expensive, and the laws of some foreign countries do not protect intellectual property rights to the same
extent as the laws of the U.S. Many companies have encountered significant problems in protecting and defending
intellectual property rights in certain foreign jurisdictions. This could make it difficult for us to stop infringement of our
foreign patents, if obtained, or the misappropriation of our other intellectual property rights. For example, some foreign
countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition,
some countries limit the enforceability of patents against third parties, including government agencies or government
contractors. In these countries, patents may provide limited or no benefit. Patent protection must ultimately be sought on a
country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we
may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such
countries. Additionally, in the event that our trademarks are successfully challenged, we could be forced to rebrand our
products, which could result in loss of brand recognition and could require us to devote resources to advertising and
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marketing new brands. Our competitors may infringe our trademarks, and we may not have adequate resources to enforce
our trademarks.
Proceedings to enforce our patent or trademark rights in foreign jurisdictions could result in substantial costs and divert our
efforts and attention from other aspects of our business. Accordingly, our efforts to protect our intellectual property rights
in such countries may be inadequate.
Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information
or misappropriated trade secrets.
We employ individuals who previously worked with other companies, including our competitors. Although we try to
ensure that our employees and consultants do not use the proprietary information or know-how of others in their work for
us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or
otherwise used or disclosed intellectual property or personal data, including trade secrets or other proprietary information,
of a former employer or other third party. Litigation may be necessary to defend against these claims. If we fail in
defending any such claims or settling those claims, in addition to paying monetary damages or a settlement payment, we
may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims,
litigation could result in substantial costs and be a distraction to management and other employees.
Recent changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents.
The U.S. has recently enacted and implemented wide ranging patent reform legislation. The U.S. Supreme Court has ruled
on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or
weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability
to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once
obtained. Depending on actions by the U.S. Congress, the U.S. federal courts, and the USPTO, the laws and regulations
governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce
patents that we have licensed or that we might obtain in the future. Similarly, changes in patent law and regulations in other
countries or jurisdictions, changes in the governmental bodies that enforce them or changes in how the relevant
governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce
patents that we have licensed or that we may obtain in the future.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document
submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection
could be reduced or eliminated for non-compliance with these requirements.
The USPTO and other patent agencies require compliance with a number of procedural, documentary, fee payment and
other similar provisions during the patent application process. In addition, periodic maintenance and annuity fees on any
issued patent are due to be paid to the USPTO and other patent agencies over the lifetime of the patent. While an
inadvertent failure to make payment of such fees or to comply with such provisions can in many cases be cured by
additional payment of a late fee or by other means in accordance with the applicable rules, there are situations in which
non-compliance with such provisions will result in the abandonment or lapse of the patent or patent application, and the
partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in
abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time
limits, non-payment of fees and failure to properly legalize and submit formal documents within prescribed time limits. If
we or our licensors fail to maintain the patents and patent applications covering our product or if we or our licensors
otherwise allow our patents or patent applications to be abandoned or lapse, it can create opportunities for competitors to
enter the market, which would hurt our competitive position and could impair our ability to successfully commercialize our
products.
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Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount
of time.
The term of any individual patent depends on applicable law in the country where the patent is granted. In the U.S.,
provided all maintenance fees are timely paid, a patent generally has a term of 20 years from its application filing date or
earliest claimed non-provisional filing date. Extensions may be available under certain circumstances, but the life of a
patent and, correspondingly, the protection it affords is limited. Even if we or our licensors obtain patents covering our
products, when the terms of all patents covering a product expire, our business may become subject to competition from
products identical or similar to ours. As a result, our owned and licensed patent portfolio may not provide us with sufficient
rights to exclude others from commercializing products similar or identical to ours.
We may be unable to obtain a patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries
under similar legislation.
In the U.S., a patent that covers a drug product or medical device approved by the FDA may be eligible for a term
extension designed to restore the period of the patent term that is lost during the premarket regulatory review process
conducted by the FDA. Depending upon the timing, duration and conditions of FDA marketing approval of our products,
one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and
Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, which permits a patent term extension of up to five years
for a patent covering an approved product as compensation for effective patent term lost during product development and
the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of
14 years from the date of product approval, and only claims covering such approved drug product, a method for using it or
a method for manufacturing it may be extended. In the European Union, our product candidates may be eligible for term
extensions based on similar legislation. In either jurisdiction, however, we may not receive an extension if we fail to apply
within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable
requirements. Even if we are granted such extension, the duration of such extension may be less than our request. If we are
unable to obtain a patent term extension, or if the term of any such extension is less than our request, the period during
which we can enforce our patent rights for that product will be in effect shortened and our competitors may obtain approval
to market competing products sooner. The resulting reduction of years of revenue from applicable products could be
substantial.
Intellectual property rights do not necessarily address all potential threats.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights
have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For
example:
● others may be able to make products that are similar to our products or utilize similar technology but that are
not covered by the claims of our patents or that incorporate certain technology in our products that is in the
public domain;
● we, or our future licensors or collaborators, might not have been the first to make the inventions covered by
the applicable issued patent or pending patent application that we own now or may own or license in the
future;
● we, or our future licensors or collaborators, might not have been the first to file patent applications covering
certain of our or their inventions;
● we may not be able to successfully commercialize our products before our relevant patents we may have, or
to which we have ownership rights through licensing agreements, expire;
● others may independently develop similar or alternative technologies or duplicate any of our technologies
without infringing our intellectual property rights;
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● it is possible that our current or future pending patent applications will not lead to issued patents;
● issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal
challenges by our competitors or other third parties;
● our competitors or other third parties might conduct research and development activities in countries where
we do not have patent rights and then use the information learned from such activities to develop competitive
products for sale in our major commercial markets;
● we may not develop additional proprietary technologies that are patentable;
● the patents of others may harm our business; and
● we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party
may subsequently file a patent covering such intellectual property.
Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Risks Related to Government Regulation
Our products and operations are subject to extensive government regulation and oversight both in the U.S. and
internationally.
Our products are regulated as medical devices. We and our products are subject to extensive regulation in the U.S. and
internationally including by the FDA and competent authorities of the EU member states. The FDA and other foreign
equivalents regulate, among other things, with respect to medical devices: design, development and manufacturing; testing,
labeling, content and language of instructions for use and storage; clinical trials; product safety; establishment registration
and device listing; marketing, sales and distribution; premarket clearance and approval; record keeping procedures;
advertising and promotion; recalls and field safety corrective actions; post-market surveillance, including reporting of
deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; post-market
approval studies; and product import and export.
The regulations to which we are subject are complex, have become more stringent over time and are subject to further
change. Failure to comply with applicable regulations could jeopardize our ability to sell our products and result in
enforcement actions such as: warning letters; untitled letters; Form 483s; fines; injunctions; civil penalties; termination of
distribution; recalls or seizures of products; delays in the introduction of products into the market; total or partial
suspension of production; refusal to grant future clearances or approvals; withdrawals or suspensions of current approvals,
resulting in prohibitions on sales of our products; and in the most serious cases, criminal penalties.
We may not receive, or may be significantly delayed in receiving, the necessary clearances or approvals for our future
products and modifications to our current products may require new 510(k) clearances or PMA approvals, and may
require us to cease marketing or recall the modified products until clearances or approvals are obtained.
An element of our strategy is to continue to add new features and expand the indications and uses for our current products.
In the U.S., before we can market a new medical device, or a new use of, new claim for or significant modification to an
existing product, we must first receive marketing authorization, such as either clearance under Section 510(k) of the FDCA
or approval of a PMA from the FDA, unless an exemption applies. Our products are cleared with the FDA, through
clearances obtained and, with the exception of the clearances relating to our OviTex PRS products, held by Aroa, under
Section 510(k) of the FDCA, which permits marketing of a device if it is “substantially equivalent” to an already legally-
marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a device
that was legally marketed prior to May 28, 1976 (preamendments device), a device that was originally on the U.S. market
pursuant to an approved PMA and later downclassified, or a 510(k)-exempt device. To be “substantially equivalent,” the
proposed device must have the same intended use as the predicate device,
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and either have the same technological characteristics as the predicate device or have different technological characteristics
and the information in the premarket notification demonstrates that the device is as safe and effective and does not raise
different questions of safety or effectiveness than the predicate device. Clinical data are sometimes required to support
substantial equivalence. In the PMA process, the FDA must determine that a proposed device is safe and effective for its
intended use based, in part, on extensive data, including, but not limited to, technical, preclinical, clinical trial,
manufacturing and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest
risk, such as life-sustaining, life-supporting or implantable devices. To date, our products have been the subject of cleared
510(k)s, obtained and, with the exception of the clearances relating to our OviTex PRS products, held by Aroa. For more
information regarding the regulation of our products, see “Business — Government Regulation.”
Modifications to products that are approved through a PMA application generally require FDA approval. Similarly, certain
modifications made to products cleared through a 510(k) may require a new 510(k) clearance. Both the PMA approval and
the 510(k) clearance process can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process usually takes
from three to 12 months, but can last longer. The process of obtaining a PMA is much more costly and uncertain than the
510(k) clearance process and generally takes from one to three years, or even longer, from the time the application is filed
with the FDA. In addition, a PMA generally requires the performance of one or more clinical trials. Despite the time, effort
and cost, we cannot assure you that any particular device will be approved or cleared by the FDA. Any delay or failure to
obtain necessary regulatory clearances or approvals could harm our business.
In the U.S., Aroa has obtained and holds 510(k) clearances from the FDA to market our OviTex products and obtained the
510(k) clearances from the FDA held by us for our first two OviTex PRS products, while we obtained and hold the 510(k)
clearance for our OviTex PRS Long-Term Resorbable product. An element of our strategy is to continue to upgrade our
reinforced tissue matrix products. We expect that any such modifications may require new 510(k) clearances; however,
future modifications may be subject to the substantially more costly, time-consuming and uncertain PMA process. The
FDA will require a PMA, rather than a 510(k) clearance for the use of OviTex PRS in breast surgery. If the FDA requires
us to go through a lengthier, more rigorous examination for future products or modifications to existing products than we
had expected, product introductions or modifications could be delayed or canceled, which could cause our sales to decline.
The FDA can delay, limit or deny clearance or approval of a device for many reasons, including:
● we may not be able to demonstrate to the FDA’s satisfaction that the product or modification is substantially
equivalent to the proposed predicate device or safe and effective for its intended use;
● the data from our preclinical studies and clinical trials may be insufficient to support clearance or approval,
where required; and
● the manufacturing process or facilities we use may not meet applicable requirements.
In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing
regulations, or take other actions which may prevent or delay approval or clearance of our future products under
development.
Even after we have obtained the proper regulatory clearance or approval to market a product, we have ongoing
responsibilities under FDA regulations. The failure to comply with applicable regulations could jeopardize our ability to
sell our reinforced tissue matrix products and result in enforcement actions such as:
● warning letters, untitled letters or Form 483s;
● fines;
● injunctions;
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● civil penalties;
● termination of distribution;
● recalls or seizures of products;
● delays in the introduction of products into the market;
● total or partial suspension of production;
● refusal to grant future clearances or approvals;
● withdrawals or suspensions of current clearances or approvals, resulting in prohibitions on sales of our
products; and
● in the most serious cases, criminal penalties.
Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and harm our reputation,
business, financial condition and results of operations.
In addition, regulators may determine that our financial relationships with our principal investigators resulted in a
perceived or actual conflict of interest that may have affected the interpretation of a study. Principal investigators for our
clinical trials may serve as speakers or consultants to us from time to time and receive compensation in connection with
such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or other
regulatory authority. The FDA or other regulatory authority may conclude that a financial relationship between us and a
principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or other
regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the
utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing
applications by the FDA or other regulatory authority, as the case may be, and may ultimately lead to the denial of
marketing approval of one or more of our future products.
To sell our products in member countries of the EEA our products must comply with the general safety and performance
requirements of the EU Medical Devices Regulation (Regulation 2017/745) (“MDR”), which was passed by the EU
Parliament on April 5, 2017, and became effective on May 26, 2021. The MDR repeals and replaces the former Medical
Devices Directive (Council Directive 93/42/EEC) and the Active Implantable Medical Devices Directive (Council
Directive 90/385/EEC). Compliance with the new MDR requirements is a prerequisite to be able to affix the Conformité
Européenne, or CE, mark to our products, without which they cannot be sold or marketed in the EEA. In the EEA, we have
obtained the CE mark for our OviTex products. For more information regarding regulation of our products, see “Business
—Government Regulation.”
An element of our strategy is to continue to add new features and expand the indications and uses for our current products.
Any modification to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would
constitute a major change in its intended use, design or manufacture, requires a new 510(k) clearance or, possibly, approval
of a PMA. The FDA requires every manufacturer to make this determination in the first instance, but the FDA may review
any manufacturer’s decision. The FDA may not agree with our decisions regarding whether new clearances or approvals
are necessary. Such modifications can be expensive and uncertain in time and outcome. We may not be able to obtain
additional 510(k) clearances or PMAs for new products or for modifications to, or additional indications for, our products
in a timely fashion, or at all. Delays in obtaining required future clearances or approvals would adversely affect our ability
to introduce new or enhanced products in a timely manner, which in turn would harm our future growth. We have made
modifications to our products in the past and expect to make additional modifications in the future that we believe do not or
will not require additional clearances or approvals. If the FDA disagrees and requires new clearances or approvals for these
modifications, we may be required to recall and to stop selling or marketing such products as modified until we obtain
clearance or approval, which could harm our operating results and require us to
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redesign such products. In these circumstances, we may be subject to significant enforcement actions, including significant
fines or penalties.
International regulatory approval processes may take more or less time than the FDA clearance or approval process. If we
fail to comply with applicable FDA and comparable non-U.S. regulatory requirements, we may not receive regulatory
clearances or approvals or may be subject to FDA or comparable non-U.S. enforcement actions.
We may be unable to obtain future regulatory clearance or approval in a timely manner, or at all, especially if existing
regulations are changed or new regulations are adopted. For example, the FDA clearance or approval process can take
longer than anticipated due to requests for additional clinical data and changes in regulatory requirements. A failure or
delay in obtaining necessary regulatory clearances or approvals would materially adversely affect our business, financial
condition and results of operations.
Although we have obtained regulatory clearance for our products, they will remain subject to extensive regulatory
scrutiny.
We are subject to ongoing and pervasive regulatory requirements governing, among other things, the manufacturing,
marketing, advertising, medical device reporting, selling and promoting our products. For example, we must submit
periodic reports to the FDA as a condition of our clearance under Section 510(k). These reports include safety and
effectiveness information about the device after its clearance. Failure to submit such reports, or failure to submit the reports
in a timely manner, could result in enforcement action by the FDA.
Even after we have obtained the proper regulatory approval to market our products, they will be subject to ongoing
regulatory requirements for design, development, manufacturing, testing, labeling, packaging, storage, advertising,
promotion, sampling, record-keeping, recalls and field safety corrective actions, conduct of post-marketing studies and
submission of safety, effectiveness and other post-market information, including both federal and state requirements in the
U.S. and requirements of comparable non-U.S. regulatory authorities. Our failure to comply with applicable regulatory
requirements could result in enforcement action by the FDA and applicable state regulatory authorities, which may include
any of the following sanctions:
● issue warning or untitled letters that would result in adverse publicity or may require corrective advertising;
● fines, injunctions, consent decrees and civil penalties;
● recalls, termination of distribution, administrative detention, or seizure of our products;
● customer notifications or repair, replacement or refunds;
● operating restrictions or partial suspension or total shutdown of production;
● delays in or refusal to grant our requests for future clearances under Section 510(k) or premarket approvals or
EU regulatory approvals of new products, new intended uses, or modifications to existing products;
● withdrawal or suspension of regulatory clearances or approvals;
● FDA refusal to issue certificates to non-U.S. governments needed to export products for sale in other
countries; and
● criminal prosecution.
Any government investigation of alleged violations of law could require us to expend significant time and resources in
response, and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may
significantly and adversely affect our ability to commercialize and generate revenue from our products. If regulatory
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sanctions are applied or if regulatory clearance or approval is withdrawn, it would have a material adverse effect on our
business, financial condition and results of operations.
Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall
our products or terminate production if we fail to comply with these regulations.
The methods used in, and the facilities used for, the manufacture of our products must comply with the FDA’s QSR which
is a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process
controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing and shipping of
medical devices. Furthermore, Aroa must maintain facilities, procedures and operations that comply with our quality
standards and applicable regulatory requirements. The FDA enforces the QSR through periodic announced or unannounced
inspections of medical device manufacturing facilities, which may include the facilities of subcontractors. Our products are
also subject to similar state regulations and various EU laws and regulations governing manufacturing.
Aroa may not take the necessary steps to comply with applicable regulations, which could cause delays in the delivery of
our products. For example, following an inspection in March 2017, Aroa received an FDA Form 483 that contained
multiple observations related to its manufacturing processes and procedures. In addition, failure to comply with applicable
FDA requirements or later discovery of previously unknown problems with our products or manufacturing processes could
result in, among other things: untitled letters or warning letters; fines, injunctions or civil penalties; suspension or
withdrawal of approvals; seizures or recalls of our products; total or partial suspension of production or distribution;
administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or future clearances or approvals for our
products; clinical holds; refusal to permit the import or export of our products; and criminal prosecution of us or our
employees.
Any of these actions could significantly and negatively affect the supply of our products. If any of these events occurs, our
reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience
reduced sales and increased costs.
If guidelines for soft-tissue reconstruction surgery change or the standard of care evolves, we may need to redesign and
seek new marketing authorization from the FDA for our OviTex and OviTex PRS products or other products we may
commercialize in the future.
If guidelines for soft-tissue reconstruction surgery change or the standard of care for reconstructing tissue evolves, we may
need to redesign the applicable product and seek new approvals from the FDA. Our clearances under Section 510(k) of the
FDCA are based on current soft-tissue reconstruction surgery guidelines. If the guidelines change so that different surgeries
or products become desirable, the clinical utility of one or more of our OviTex and OviTex PRS products or other products
we may commercialize in the future could be diminished and our business could be adversely affected.
If any of our products cause or contribute to a death, serious injury, or other adverse medical events, or malfunction in
certain ways, we will be required to report these events to FDA and other comparable regulatory authorities under
applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement
actions. If we fail to comply with our reporting obligations, we would be subject to sanctions that could harm our
reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products,
or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a
negative impact on us.
We are subject to the FDA’s medical device reporting regulations and similar EU and other foreign regulations, which
require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more
of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the
malfunction were to recur, could cause or contribute to a death or serious injury. The timing of our obligation to report is
triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report
adverse events of which we become aware within the prescribed timeframe. We may also fail to recognize that we have
become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse
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event that is unexpected or removed in time from the use of the product. If we fail to comply with our reporting
obligations, the FDA could take action, including untitled letters, warning letters, administrative actions, criminal
prosecution, imposition of civil monetary penalties, revocation of related approvals, seizure of our products or delay in
clearance or approval of future products.
The FDA and foreign regulatory agencies have the authority to require the recall of commercialized products in the event
of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an
unacceptable risk to health. The FDA’s authority to require a recall must be based on a finding that there is reasonable
probability that the device could cause serious injury or death. We may also choose to voluntarily recall a product if any
material deficiency is found. For example, in April 2018, Aroa, as the product manufacturer, issued a voluntary recall of
our resorbable OviTex products due to a reduction in the labeled shelf life of such products from 24 months to 18 months.
The recall included a total of 1,974 units from 48 manufacturing lots and was ultimately terminated in April 2019. A
government-mandated or voluntary recall by us could also occur as a result of an unacceptable risk to health, component
failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or
failures to comply with applicable regulations. Product defects or other errors may occur in the future.
Depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may
decide, that we will need to obtain new clearances or approvals for the device before we may market or distribute the
corrected device. Seeking such approvals may delay our ability to replace the recalled devices in a timely manner.
Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory
enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties or civil or
criminal fines.
Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA.
We may initiate voluntary withdrawals or corrections for our products in the future that we determine do not require
notification of the FDA. If the FDA disagrees with our determinations, it could require us to report those actions as recalls
and we may be subject to enforcement action. A future recall announcement could harm our reputation with customers,
potentially lead to product liability claims against us and negatively affect our sales. Any corrective action, whether
voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital,
distract management from operating our business and may harm our reputation and financial results.
Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearances or
approvals for our products or to manufacture, market or distribute our products after clearance or approval is obtained.
From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions
governing the regulation of medical devices, or the FDA may change its clearance and approval policies, adopt additional
regulations or revise existing regulations, or take other actions which may prevent or delay approval or clearance of our
future products under development. In addition, FDA regulations and guidance are often revised or reinterpreted by the
FDA in ways that may significantly affect our business and our products. Any new statutes, regulations or revisions or
reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or
make it more difficult to obtain clearance of or approval for, manufacture, market or distribute our products. We cannot
determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or
adopted may have on our business in the future. Such changes could, among other things, require: additional testing prior
to obtaining clearance or approval; changes to manufacturing methods; recall, replacement or discontinuance of our
products; or additional record keeping.
The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted
that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or
extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if
we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we
may not achieve or sustain profitability.
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On April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals
and replaces the EU Medical Devices Directive and the Active Implantable Medical Devices Directive. Unlike directives,
which must be implemented into the national laws of the EEA member states, the regulations would be directly applicable,
i.e., without the need for adoption of EEA member state laws implementing them, in all EEA member states and are
intended to eliminate current differences in the regulation of medical devices among EEA member states. The Medical
Devices Regulation is intended to, among other things, establish a uniform, transparent, predictable and sustainable
regulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting
innovation.
The MDR became fully effective on May 26, 2021. It includes new regulations which, among other things:
● strengthen the rules on placing devices on the market and reinforce surveillance once they are available;
● establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance
and safety of devices placed on the market;
● improve the traceability of medical devices throughout the supply chain to the end-user or patient through a
unique identification number;
● establish a central database to provide patients, healthcare professionals and the public with comprehensive
information on products available in the EU; and
● strengthen rules for the assessment of certain high-risk devices, which may have to undergo an additional
check by experts before they are placed on the market.
Failure to comply with these regulations may harm our business.
Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key
leadership and other personnel, or otherwise prevent new products and services from being developed or
commercialized in a timely manner.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government
budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory,
regulatory, and policy changes. Average review times at the FDA have fluctuated in recent years as a result. In addition,
government funding of other government agencies that fund research and development activities is subject to the political
process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time necessary for new devices to be reviewed and/or
approved or cleared by necessary government agencies, which would adversely affect our business. For example, over the
last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have
had to furlough critical FDA employees and stop critical activities. If a prolonged government shutdown occurs, it could
significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a
material adverse effect on our business.
Our relationships with surgeons, patients and payors in the U.S. are subject to applicable anti-kickback, fraud and
abuse laws and regulations.
Our current and future operations with respect to the commercialization of our products are subject to various U.S. federal
and state healthcare laws and regulations. These laws impact, among other things, our proposed sales, marketing, support
and education programs and constrain our business and financial arrangements and relationships with third-party payors,
surgeons and other healthcare professionals. For more information, see the sections entitled “Business –
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Government Regulation – Anti-Kickback Statutes, – False Claims Laws; – Transparency Laws; and – Other Federal
Healthcare Fraud and Abuse Laws” in this Annual Report.
The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to
comply with different compliance or reporting requirements in multiple jurisdictions increase the possibility that a
healthcare or medical device company may fail to comply fully with one or more of these requirements. Efforts to ensure
that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve
substantial costs. Certain physicians who influence the ordering or use of our products in procedures they perform have
ownership interests in us and/or receive compensation for consulting services provided to us. It is possible that
governmental authorities will conclude that our business practices do not comply with applicable fraud and abuse or other
healthcare laws and regulations or guidance.
To enforce compliance with healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny
of interactions between healthcare companies and healthcare providers, which has led to a number of investigations,
prosecutions, convictions and settlements in the healthcare industry. Responding to investigations can be time- and
resource-consuming and can divert management’s attention from the business. Additionally, as a result of these
investigations, healthcare providers and entities may also have to agree to additional compliance and reporting
requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlements could
increase our costs or otherwise have an adverse effect on our business. Even an unsuccessful challenge or investigation into
our practices could cause adverse publicity and be costly to respond to.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to
us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion
from government funded healthcare programs, such as Medicare and Medicaid, additional oversight and reporting
requirements if we become subject to a corporate integrity agreement to resolve allegations of non-compliance with these
laws and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with
whom we expect to do business is found not to be in compliance with applicable laws, they may be subject to the same
criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
We are subject to anti-bribery, anti-corruption, and anti-money laundering laws, including the U.S. Foreign Corrupt
Practices Act, in which violations of these laws could result in substantial penalties and prosecution.
We are exposed to trade and economic sanctions and other restrictions imposed by the U.S. and other governments and
organizations. The U.S. Departments of Justice, Commerce, State and Treasury and other federal agencies and authorities
have a broad range of civil and criminal penalties they may seek to impose against corporations and individuals for
violations of economic sanctions laws, export control laws, the U.S. Foreign Corrupt Practices Act, or the FCPA, and other
federal statutes and regulations, including those established by the Office of Foreign Assets Control. In addition, the U.K.
Bribery Act of 2010 (“Bribery Act”), prohibits both domestic and international bribery, as well as bribery across both
private and public sectors. An organization that “fails to prevent bribery” by anyone associated with the organization can
be charged under the Bribery Act unless the organization can establish the defense of having implemented “adequate
procedures” to prevent bribery. Under these laws and regulations, as well as other anti-corruption laws, anti-money
laundering laws, export control laws, customs laws, sanctions laws and other laws governing our operations, various
government agencies may require export licenses, may seek to impose modifications to business practices, including
cessation of business activities in sanctioned countries or with sanctioned persons or entities and modifications to
compliance programs, which may increase compliance costs, and may subject us to fines, penalties and other sanctions. A
violation of these laws or regulations would negatively affect our business, financial condition and results of operations.
We face risks related to our collection and use of data, which could result in investigations, inquiries, litigation, fines,
legislative and regulatory action and negative press about our privacy and data protection practices.
Our business processes personal data, including some data related to health. When conducting clinical trials, we face risks
associated with collecting trial participants’ data, especially health data, in a manner consistent with applicable
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laws and regulations. We also face risks inherent in handling large volumes of data and in protecting the security of such
data. We could be subject to attacks on our systems by outside parties or fraudulent or inappropriate behavior by our
service providers or employees. Third parties may also gain access to users’ accounts using stolen or inferred credentials,
computer malware, viruses, spamming, phishing attacks or other means, and may use such access to obtain users’ personal
data or prevent use of their accounts. Further, our general liability insurance and corporate risk program may not cover all
potential claims to which we are exposed and may not be adequate to indemnify us for all liability that may be imposed.
As our operations and business grow, we may become subject to or affected by new or additional data protection laws and
regulations and face increased scrutiny or attention from regulatory authorities. In the U.S., HIPAA imposes, among other
things, certain standards relating to the privacy, security, transmission and breach reporting of individually identifiable
health information. Certain states have also adopted comparable privacy and security laws and regulations, some of which
may be more stringent than HIPAA. Such laws and regulations will be subject to interpretation by various courts and other
governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic
partners. In addition, California enacted the CCPA on June 28, 2018, which took effect on January 1, 2020. The CCPA
created individual privacy rights for California consumers and increased the privacy and security obligations of entities
handling certain personal data. The CCPA provides for civil penalties for violations, as well as a private right of action for
data breaches in certain instances that is expected to increase data breach litigation. The CCPA may increase our
compliance costs and potential liability, and many similar laws have been proposed at the federal level and in other states.
Additionally, the California Privacy Rights Act, or the CPRA, took effect in most material respects on January 1, 2023. The
CPRA modifies the CCPA significantly, potentially resulting in further uncertainty and requiring us to incur additional
costs and expenses to comply. A failure to comply with these current or future federal and state laws and regulations and
industry standards relating to data privacy and security could lead to investigatory or regulatory action, private litigation or
class actions that could result in exposure to civil or criminal penalties, monetary or statutory damages, attorney fee awards
and/or exposure to adverse publicity that could negatively affect our operating results and business.
This risk is enhanced in certain jurisdictions as we expand our operations internationally. The EU’s GDPR became
effective in May 2018. The GDPR applies extraterritorially and imposes several stringent requirements for controllers and
processors of personal data, of data subjects residing in the European Economic Area. For example, the GDPR imposes
higher standards for obtaining consent from individuals to process their personal data, more robust disclosures to
individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations
on retention of information, increased requirements pertaining to special categories of personal data and pseudonymised
(i.e., key-coded) data and additional obligations when we contract third-party processors in connection with the processing
of the personal data. This risk is increased because EU member states have made their own laws and regulations limiting
the processing of personal data, including special categories of data (e.g., racial or ethnic origin, political opinions,
religious or philosophical beliefs) and profiling and automated individual decision-making of individuals, which limits our
ability to process personal data or other data and could cause our compliance costs and liability risks to increase, harming
our business and financial condition.
Further, the United Kingdom’s exit from the European Union, referred to as Brexit, has created uncertainty regarding data
protection regulation in the United Kingdom. The United Kingdom has transposed the GDPR into domestic law with a
United Kingdom version of the GDPR that took effect in January 2021 (UK GDPR). Currently, the EU GDPR and UK
GDPR remain largely aligned, but the UK has announced plans to reform the country’s data protection legal framework in
its Data Reform Bill, which will introduce significant changes from the EU GDPR. This may lead to additional compliance
costs and could increase our overall risk exposure as we may no longer be able to take a unified approach across the EEA
and the UK, and we will need to amend our processes and procedures to align with the new framework. Non-compliance
with GDPR, and UK GDPR, is subject to significant penalties, including fines of up to €20.0 million (£17.5 million under
UK GDPR) or 4% of total worldwide revenue, whichever is greater. The implementation and enforcement of the GDPR
(and UK GDPR) may subject us to enforcement risk and requirements to change certain of our data collection, processing
and other policies and practices. We could incur significant costs investigating and defending such claims and, if we are
found liable, significant damages. If any of these events were to occur, our business and financial results could be adversely
affected. Other jurisdictions outside the EU and the United
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Kingdom are similarly introducing or enhancing laws and regulations relating to privacy and data security, which enhances
risks relating to compliance with such laws.
The GDPR also regulates cross-border transfers of personal data and requires transferee countries to have protections
equivalent to protections available in the EU. The GDPR imposes strict rules on the transfer of personal data to countries
outside the EEA, Switzerland or the United Kingdom, including the United States, to other countries in respect of which
the European Commission or the United Kingdom government has not issued a so-called “adequacy decision” or “
adequacy regulation” (known as “third countries”), unless the parties to the transfer have implemented specific safeguards
to protect the transferred personal data. This includes putting in place the European Commission’s Standard Contractual
Clauses (SCCs) for transfers outside of the EEA and a similar transfer mechanism for transfers of personal data outside of
the United Kingdom, the International Data Transfer Agreement or Addendum (IDTA). Under both the GDPR and the UK
GDPR, exporters are also required to assess the risk of the data transfer on a case-by-case basis, including conducting an
analysis of the laws in the destination country. The SCCs had to be in place by December 27, 2022, whereas the IDTA had
to be implemented in all existing contracts by March 21, 2024. Finalizing the implementation of the updated SCCs and
UK IDTA, and conducting the required risk assessments, may continue to necessitate significant contractual overhaul of
our data transfer arrangements with customers, sub-processors and vendors. On June 28, 2021, the European Commission
published its decision recognizing the United Kingdom as having adequate laws to the protect the rights and freedoms of
data subjects such that personal data may transfer to from the EU to the United Kingdom without an approved transfer
mechanism. The decision is effective for four years and its continuing effect is dependent on United Kingdom and
regulation on data privacy not diverging materially from the GDPR. The United Kingdom Government also confirmed that
data transfers to the EU remain free flowing.
Compliance with U.S. federal and state laws and foreign data protection laws and regulations could require us to take on
more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our
ability to operate in certain jurisdictions. Failure to comply with United States and foreign data protection laws and
regulations could result in government enforcement actions (which could include civil or criminal penalties), private
litigation, and/or adverse publicity and could negatively affect our operating results and business. And claims that we have
violated individuals’ privacy rights, failed to comply with data protection laws or breached our contractual obligations,
even if we are not found liable, could be expensive and time-consuming to defend, could result in adverse publicity and
could have a material adverse effect on our business, financial condition, results of operations, and prospects.
The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to successfully
commercialize our products and affect the prices we may obtain.
Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by
requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling;
(iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were
to be imposed, they could adversely affect the operation of our business. For more information, see the section entitled
“Business – Government Regulation – U.S. Healthcare Reform” in this Annual Report.
In the U.S., for example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education
Affordability Reconciliation Act, or collectively the Affordable Care Act, substantially changed the way healthcare is
financed by both governmental and private insurers, and significantly impacts the healthcare industry. The Affordable Care
Act is intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance
remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance
industries, impose new taxes and fees on pharmaceutical and medical device manufacturers, and impose additional health
policy reforms.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control
healthcare costs, including price or patient reimbursement constraints, discounts, restrictions on certain product access and
marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other
countries and bulk purchasing.
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We expect that additional federal, state and foreign healthcare reform measures will be adopted in the future, any of which
could limit the amounts that federal and state governments will pay for healthcare products and services, which could result
in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing
pressures. and could seriously harm our future revenues. Any reduction in reimbursement from Medicare, Medicaid, or
other government programs may result in a similar reduction in payments from private payers. The implementation of cost
containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain and maintain
profitability of our product and product candidates, if approved.
Our business involves the use of hazardous materials and we and Aroa must comply with environmental laws and
regulations, which may be expensive and restrict how we do business.
Aroa’s activities in manufacturing our products may involve the controlled storage, use and disposal of hazardous
materials. Aroa is or may be subject to federal, state, local and non-U.S. laws and regulations governing the use,
generation, manufacture, storage, handling and disposal of these hazardous materials. We currently carry no insurance
specifically covering environmental claims relating to the use of hazardous materials.
Although we believe that Aroa’s safety procedures for handling and disposing of these materials and waste products
comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental injury or
contamination from the use, storage, handling or disposal of hazardous materials. In the event of an accident, federal, state
or other applicable authorities may curtail Aroa’s use of these materials and interrupt their business operations which could
adversely affect our business.
Compliance with environmental laws and regulations may be expensive and non-compliance could result in substantial
liabilities, fines and penalties, personal injury and third-party property damage claims and substantial investigation and
remediation costs. Environmental laws and regulations could become more stringent over time, imposing greater
compliance costs and increasing risks and penalties associated with violations. We cannot assure you that violations of
these laws and regulations will not occur in the future or have not occurred in the past as a result of human error, accidents,
equipment failure or other causes. The expense associated with environmental regulation and remediation could harm our
financial condition and results of operations.
Risks Related to Our Business and Products
Our financial results may fluctuate significantly and may not fully reflect the underlying performance of our business.
Our quarterly and annual results of operations may vary significantly in the future, and period-to-period comparisons of our
operating results may not be meaningful. Accordingly, the results of any one quarter or period should not be relied upon as
an indication of future performance. Our quarterly and annual financial results may fluctuate as a result of a variety of
factors, many of which are outside our control.
Factors that may cause fluctuations in our quarterly and annual results include:
● surgeon and patient adoption of our products;
● timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors;
● changes in coverage policies by third-party payors that affect the reimbursement of procedures in which our
products are used;
● unanticipated pricing pressure;
● our ability to obtain and maintain regulatory clearance or approval for any products in development or for
our current products for additional indications or in additional jurisdictions;
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● the hiring, retention and continued productivity of our sales representatives;
● our ability to expand the geographic reach of our sales and marketing efforts;
● results of clinical research and trials on our existing products and products in development;
● delays in, or failure of, component and raw material deliveries by Aroa;
● recalls or other field safety corrective actions by Aroa;
● business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters
such as earthquakes, floods or public health emergencies such as the COVID-19 pandemic; and
● positive or negative coverage in the media or clinical publications of our products or products of our
competitors or our industry.
Because our quarterly and annual results may fluctuate, period-to-period comparisons may not be the best indication of the
underlying results of our business. These fluctuations may also increase the likelihood that we will not meet our forecasted
performance, which could negatively affect the market price for our common stock.
We may be unable to compete successfully with larger competitors in our highly competitive industry.
The medical device industry is intensely competitive, subject to rapid change and significantly affected by new product
introductions and other market activities of industry participants. Our competitors also compete with us in recruiting and
retaining qualified scientific, management and commercial personnel, as well as in acquiring technologies complementary
to, or necessary for, our products. Because of the complex and technical nature of our products and the dynamic market in
which we compete, any failure to attract and retain a sufficient number of qualified employees could materially harm our
ability to develop and commercialize our products, which would have a material adverse effect on our business, financial
condition and results of operations.
In the U.S., we currently compete with LifeCell Corporation, a subsidiary of AbbVie, Davol Inc., a subsidiary of Becton,
Dickinson and Company, MTF Biologics and RTI Surgical, which produce, among other things, soft-tissue reconstruction
surgery products, including Strattice and Alloderm, Phasix, FlexHD and Cortiva, respectively. In the EEA, we compete
with Bard, a subsidiary of Becton, Dickinson and Company, who produces other soft-tissue reinforcement products. Many
of these competitors are large, well-capitalized companies with significantly greater market share and resources than us,
selling products that have been on the market prior to the commercialization of our products. As a consequence, they are
able to spend more on product development, marketing, sales and other product initiatives than we can, while benefiting
from greater brand awareness. We believe other emerging businesses are in the early stages of developing similar products
designed for soft-tissue reconstruction surgery. Although we are the only ovine-derived implantable product designed for
soft-tissue reconstruction surgery, there are other soft tissue reconstruction surgery products derived solely, or in part, from
other biological sources.
Most of the other soft-tissue reconstruction surgery products currently have a greater penetration into the soft tissue
reconstruction surgery market. Often, other soft-tissue reconstruction surgery products with which our products compete
are marketed as part of a bundled product line, which may provide our potential customers a better price-per-product than
we could offer. If we are unable to penetrate the soft-tissue reconstruction surgery market or offer competitive pricing on
our products compared with products sold as part of a bundled product line, it could have a material adverse effect on our
business, financial condition and results of operations.
In addition, competitors with greater financial resources could acquire other companies to gain enhanced name recognition
and market share, as well as new technologies or products that could effectively compete with our existing products, which
may cause our revenue to decline and would harm our business.
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We may be unable to renew existing contracts with GPOs or obtain additional contract positions with major GPOs and
IDNs, for our products, and even if we are able to do so, such contracts may not generate sufficient sales of our
products.
Many existing and potential customers for our products within the U.S. are members of GPOs and IDNs, including
accountable care organizations or public-based purchasing organizations, and our business strategy is focused on entering
into major contracts with these organizations. Our products can be contracted under national tenders or with larger
hospital GPOs. GPOs and IDNs typically award contracts on a category-by-category basis through a competitive bidding
process. We are currently responding to bids and negotiating a number of GPO and IDN agreements.
We may not be able to renew existing contracts with GPOs or IDNs and due to the highly competitive nature of the bidding
process and the GPO and IDN contracting processes in the U.S., we may not be able to obtain additional contract positions
with major GPOs and IDNs for our products. If we are unable to renew existing contracts with GPOs or IDNs, our net sales
and results of operations may be materially and adversely affected. In addition, while having a contract with a major
purchaser for a given product category can facilitate sales, sales volumes of those products may not be maintained. For
example, GPOs and IDNs are increasingly awarding contracts to multiple suppliers for the same product category. Even if
we are the sole contracted supplier of a GPO or IDN for our product category, members of the GPO or IDN generally are
free to purchase from other suppliers. Furthermore, GPO and IDN contracts typically are terminable without cause upon 60
to 90 days’ notice.
Supply chain disruptions could adversely impact our operations and financial condition.
Global supply chains have been impacted because of the lingering economic impacts COVID-19 pandemic, recent
geopolitical tensions such as the ongoing Russia-Ukraine conflict and the current conflict in Israel and Gaza (including any
escalation or expansion) and other factors, and this may impact the availability of raw materials and components used in
the manufacture of our products. Additionally, even when we and our suppliers are able to source such materials and
components, they may cost more and may only be available on a delayed basis. Higher materials and component costs
could adversely affect our margins if we are unable to pass such costs along to customers in the form of price increases.
Delays in receipt of materials and components could also interrupt our production and cause us to go into backorder on
certain of our products, further exacerbating the effect of the global supply chain disruption.
We face the risk of product liability claims that could be expensive, divert management’s attention and harm our
reputation and business.
Our business exposes us to the risk of product liability claims that are inherent in the testing, manufacturing and marketing
of medical devices. This risk exists even if a product is cleared or approved for commercial sale by the FDA, and
manufactured in facilities licensed and regulated by the FDA. Any side effects, manufacturing defects or misuse associated
with our products could result in patient injury or death. The industry in which we operate has historically been subject to
extensive litigation over product liability claims, and we cannot offer any assurance that we will not face product liability
suits. We may be subject to product liability claims if our products cause, or merely appear to have caused, patient injury or
death. In addition, an injury that is caused by the activities of Aroa may be the basis for a claim against us. Product liability
claims may be brought against us by patients, healthcare providers or others selling or otherwise coming into contact with
our products. If we cannot successfully defend ourselves against product liability claims, we will incur substantial
liabilities and reputational harm. In addition, regardless of merit or eventual outcome, product liability claims may result in
substantial litigation costs, product recalls or market withdrawals, decreased sales and demand for our products and
damage to our reputation.
While we may attempt to manage our product liability exposure by proactively recalling or withdrawing from the market
any defective products, any recall or market withdrawal of our products may delay the supply of those products to our
customers and may impact our reputation. We can provide no assurance that we will be successful in initiating appropriate
market recall or market withdrawal efforts that may be required in the future or that these efforts will have the intended
effect of preventing product malfunctions and the accompanying product liability that may result. Such recalls and
withdrawals may also be used by our competitors to harm our reputation for safety or be perceived by
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patients as a safety risk when considering the use of our products, either of which could have a material adverse effect on
our business, financial condition and results of operations.
Although we have product liability insurance that we believe is appropriate, this insurance is subject to deductibles and
coverage limitations. In addition, our current product liability insurance may not continue to be available to us on
acceptable terms, if at all, and, if available, coverage may not be adequate to protect us against any future product liability
claims. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of
insured liabilities could have a material adverse effect on our business, financial condition and results of operations.
The continuing development of our products depends upon our maintaining strong working relationships with
surgeons.
The research, development, marketing and sale of our current and future products and any future product indications for
which we receive regulatory clearance or approval depend upon our maintaining working relationships with surgeons. We
rely on these professionals to provide us with considerable knowledge and experience regarding the development,
marketing and sale of our products. Surgeons assist us in clinical trials and in marketing, and as researchers, product
consultants and public speakers. If we cannot maintain our strong working relationships with these professionals and
continue to receive their advice and input, the development and marketing of our products could suffer, which could have a
material adverse effect on our business, financial condition and results of operations. At the same time, the medical device
industry’s relationship with surgeons is under increasing scrutiny by the U.S. Department of Health and Human Services
Office of Inspector General (“OIG”), the U.S. Department of Justice (“DOJ”), the state attorneys general and other foreign
and domestic government agencies. Our failure to comply with requirements governing the industry’s relationships with
surgeons or an investigation into our compliance by the OIG, the DOJ, state attorneys general and other government
agencies, could have a material adverse effect on our business, financial condition and results of operations. Additional
information regarding the laws impacting our relationships with surgeons and other healthcare professionals can be found
above under “Risks Related to Government Regulation.”
We have limited data and experience regarding the safety and efficacy of certain of our products. Results of earlier
studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such products.
Our single arm multicenter post-market clinical study, which we refer to as our BRAVO study, was fully enrolled at 92
patients. We conducted this study to support the marketing of our OviTex products for their cleared indicated uses, and do
not currently have any clinical data for use of our OviTex PRS products in patients. The long-term effects of using certain
of our products in a large number of patients have not been studied and the results of short-term clinical use of such
products do not necessarily predict long-term clinical benefits or reveal long-term adverse effects. The results of preclinical
studies and clinical studies of our products conducted to date and ongoing or future studies and trials of our current,
planned or future products may not be predictive of the results of later clinical trials, and interim results of a clinical trial
do not necessarily predict final results. Our interpretation of data and results from our clinical trials do not ensure that we
will achieve similar results in future clinical trials in other patient populations. In addition, preclinical and clinical data are
often susceptible to various interpretations and analyses, and many companies that have believed their products performed
satisfactorily in preclinical studies and earlier clinical trials have nonetheless failed to replicate results in later clinical
trials. Products in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed
through nonclinical studies and earlier clinical trials.
Interim or preliminary data from our clinical trials that we announce or publish from time to time may change as more
patient data become available and are subject to audit and verification procedures that could result in material changes
in the final data.
From time to time, we may publicly disclose interim or preliminary data from our clinical studies, which is based on a
preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change
following a full analyses of all data related to the particular trial. We also make assumptions, estimations, calculations and
conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully
evaluate all data. As a result, the interim results that we report may differ from future results of the same trials,
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or different conclusions or considerations may qualify such results, once additional data have been received and fully
evaluated. Interim or preliminary data also remain subject to audit and verification procedures that may result in the final
data being materially different from the preliminary data we previously published. As a result, interim or preliminary data
should be viewed with caution until the final data are available. We may also disclose interim data from our clinical trials.
Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may
materially change as patient enrollment continues and more patient data become available. Adverse differences between
preliminary or interim data and final data could significantly harm our business prospects.
Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations,
conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the
particular program, the approvability or commercialization of the particular product candidate or product and our business
in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based
on what is typically extensive information, and you or others may not agree with what we determine is the material or
otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may
ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a
particular drug, product candidate or our business. If the interim or preliminary data that we report differ from actual
results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to use such results to
support the marketing of our products may be jeopardized.
The sizes of the markets for our current and future products have not been established with precision, and may be
smaller than we estimate.
Our estimates of the annual total addressable markets for our current products and products under development are based
on a number of internal and third-party estimates, including, without limitation, the number of hernia and soft-tissue
reconstruction surgery patients and overall market and the assumed prices at which we can sell our products. While we
believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be
correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive
accuracy of these underlying factors. As a result, our estimates of the annual total addressable market for our products may
prove to be incorrect. If the price at which we can sell future products, or the annual total addressable market for our
products is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.
Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our
products and manage our inventory.
Our reinforced tissue matrix products have a limited shelf life and will expire if not timely used. To ensure adequate
inventory supply, we must forecast inventory needs and place orders with Aroa based on our estimates of future demand
for our reinforced tissue matrix products. Our ability to accurately forecast demand for such products could be negatively
affected by many factors, including:
● product introductions by competitors;
● an increase or decrease in surgeon demand for our products or for products of our competitors;
● our failure to accurately manage our expansion strategy;
● our failure to accurately forecast surgeon acceptance of new products;
● our failure to obtain contracts with a significant number of GPOs and IDNs;
● unanticipated changes in general market conditions or regulatory matters;
● the severity and duration of market disruptions as a result of the COVID-19 outbreak; and
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● weakening of economic conditions or consumer confidence.
Inventory levels in excess of customer demand may result in inventory write-downs or write-offs, which would cause our
gross margin to be adversely affected and could impair the strength of our brand. Additionally, we are subject to the risk
that a portion of our inventory will expire, which could have a material adverse effect on our earnings and cash flows due
to the resulting costs associated with the inventory impairment charges and costs required to replace such inventory.
Conversely, if we underestimate customer demand for our products, Aroa may not be able to deliver products to meet our
requirements, and this could result in damage to our reputation and customer relationships. In addition, if we experience a
significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be
available when required on terms that are acceptable to us, or at all, or Aroa may not be able to allocate sufficient capacity
to meet our increased requirements, which could have an adverse effect on our ability to meet customer demand for our
products and our results of operations.
We rely on our own direct sales force for our products, which may result in higher fixed costs than our competitors and
may slow our ability to reduce costs.
We rely on our own direct sales force, which as of December 31, 2023 consisted of 94 representatives in the U.S. and 10
representatives in Europe, to market and sell our products. A direct sales force may subject us to higher fixed costs than
those of companies that market competing products through independent third parties, due to the costs that we will bear
associated with employee benefits, training and managing sales personnel. As a result, we may be at a competitive
disadvantage. Additionally, these fixed costs may slow our ability to reduce costs in the face of a sudden decline in demand
for our products, which could have a material adverse effect on our business, financial condition and results of operations.
Our employees, independent contractors, consultants, commercial partners, distributors and vendors may engage in
misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We are exposed to the risk that our employees, independent contractors, consultants, commercial partners and vendors may
engage in fraudulent or illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent
conduct or disclosure of unauthorized activities to us that violates: (i) the rules of the FDA and other similar foreign
regulatory bodies; (ii) manufacturing standards; (iii) healthcare fraud and abuse laws in the U.S. and similar foreign
fraudulent misconduct laws; (iv) data privacy laws and other similar non-U.S. laws; or (v) laws that require the true,
complete and accurate reporting of financial information or data. These laws may impact, among other things, future sales,
marketing and education programs.
It is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we
take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in
protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance
with such laws or regulations. In addition, we are subject to the risk that a person or government could allege such fraud or
other misconduct, even if none occurred. If any such actions are instituted against us and we are not successful in
defending ourselves or asserting our rights, those actions could result in the imposition of significant fines or other
sanctions, including the imposition of civil, criminal and administrative penalties, additional integrity reporting and
oversight obligations and possible exclusion from participation in Medicare, Medicaid and other federal healthcare
programs, any of which could adversely affect our ability to operate our business and our results of operations. Whether or
not we are successful in defending against any such actions or investigations, we could incur substantial costs, including
legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations,
which could have a material adverse effect on our business, financial condition and results of operations.
We could be adversely affected by any interruption to our ability to conduct business at our current location.
We do not have redundant facilities. We perform substantially all of our research and development and back-office activity
and maintain all our finished goods inventory in a single location in Malvern, Pennsylvania. Our facility, equipment and
inventory would be costly to replace and could require substantial lead time to repair or replace. The facility may be
harmed or rendered inoperable by natural or man-made disasters, including, but not limited to, tornadoes,
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flooding, fire, public health emergencies such as pandemics and power outages, which may render it difficult or impossible
for us to perform our customer service research, development and commercialization activities for some period of time.
The inability to perform those activities, combined with the time it may take to rebuild our inventory of finished product,
may result in the loss of customers or harm to our reputation. Although we possess insurance for damage to our property
and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and this
insurance may not continue to be available to us on acceptable terms, or at all.
If we or our vendors experience a cybersecurity incident, significant disruption or a breach of our information
technology systems, our business could be adversely affected.
We rely extensively on information technology systems to conduct our business. These systems affect, among other things,
ordering and managing products, shipping products to customers, processing transactions, summarizing and reporting
results of operations, complying with regulatory, legal and tax requirements, data security and other processes necessary to
manage our business. Our information systems require an ongoing commitment of significant resources to maintain,
protect, and enhance existing systems and develop new systems to keep pace with continuing changes in information
processing technology, evolving systems and regulatory standards, the increasing need to protect patient and customer
information, changing customer patterns and an evolving threat landscape. If our systems are damaged or cease to function
properly due to any number of causes, ranging from catastrophic events to power outages to security incidents, we may
experience interruptions in our operations or security breaches, which could have an adverse effect on our business.
If we fail to maintain or protect our information systems and data integrity effectively, we could lose existing customers,
have difficulty attracting new customers, suffer backlash from negative public relations, have regulatory sanctions or
penalties imposed, have increases in operating expenses, incur expenses or lose revenues as a result of a data privacy
breach, or suffer other adverse consequences. Furthermore, any breach in our information technology systems could lead to
the unauthorized access, disclosure and use of non-public information from our patient registry or other patient information
which is protected by HIPAA and other laws. Any such access, disclosure, or other loss of information could result in legal
claims or proceedings, liability under laws that protect the privacy of personal information and damage to our reputation.
Although we develop and maintain systems and controls designed to prevent these events from occurring, there can be no
assurance that our internal information technology systems or those of our third-party vendors will be sufficient to protect
against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction, or prevent data from
being stolen or corrupted in the event of a cyberattack, security incident, industrial espionage attacks, ransomware, or
insider threat attacks.
If a material security incident related to our information technology systems or those of our vendors occurs, the market
perception of the effectiveness of our cybersecurity measures could be harmed and our reputation and credibility could be
damaged. We could be required to expend significant amounts of money and other resources to repair or replace
information systems or networks, including costs to deploy additional personnel and protection technologies, train
employees, engage third-party experts and consultants, and identify replacement vendors if necessary, which could
materially and adversely affect our business, financial condition and results of operations. In addition, we could be subject
to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to
data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate
disclosure of data, as well as unfair or deceptive practices.
If we become profitable, our ability to use our net operating loss carryforwards and other tax attributes to offset future
taxable income or taxes may be subject to limitations.
As of December 31, 2023, we had federal and state net operating loss carry forwards (“NOLs”) of approximately $239.4
million and $196.1 million, respectively. The federal carry forwards for losses incurred prior to 2018 will begin expiring in
2032 for federal purposes. Federal net operating losses incurred in 2018 and onward have an indefinite expiration under the
2017 Tax Cut & Jobs Act. The state carry forwards will begin expiring in 2027. A full allowance for the value of the NOLs
is provided for in our audited financial statements for the year of December 31, 2023 included in this
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Annual Report on Form 10-K. We cannot guarantee what the ultimate outcome or amount of the benefit we may receive
from the NOLs, if any, will be. If we become profitable in the future, our ability to use net operating loss carryforwards and
other tax attributes to offset future taxable income or reduce taxes may be subject to limitations.
Risks Related to Our Securities
The trading price of the shares of our common stock has been and could in the future be highly volatile.
The price of our common stock has been and may continue to be volatile. Even though our common stock is listed on the
Nasdaq Global Market (“Nasdaq”), an active trading market for our common stock may not be sustained. The lack of an
active trading market may impair the value of your shares and your ability to sell your shares at the time you wish to sell
them. An inactive trading market may also impair our ability to raise capital by selling shares of our common stock and
enter into strategic partnerships or acquire other complementary products, technologies or businesses by using shares of
our common stock as consideration. Furthermore, there can be no guarantee that we will continue to satisfy the continued
listing standards of Nasdaq. If we fail to satisfy the continued listing standards, we could be de-listed, which would have a
negative effect on the price of our common stock.
We cannot predict the prices at which our shares of common stock may trade. The market price of our common stock is
likely to be highly volatile and may fluctuate substantially due to many factors, including:
● the volume and timing of sales of our products;
● the introduction of new products or product enhancements by us or others in our industry;
● disputes or other developments with respect to our or others’ intellectual property rights;
● our ability to develop, obtain regulatory clearance for, and market new and enhanced products on a timely
basis;
● product liability claims or other litigation;
● quarterly variations in our results of operations or those of others in our industry;
● media exposure of our products or of those of others in our industry;
● changes in governmental regulations or in reimbursement;
● changes in earnings estimates or recommendations by securities analysts;
● broad trends impacting companies within the pharmaceutical, biotechnology and medical technology
industries; and
● general market conditions and other factors, including factors unrelated to our operating performance or the
operating performance of our competitors, including any economic downturn as a result of the COVID-19
pandemic, or macroeconomic factors such as geopolitical tensions or the outbreak or escalation of hostilities
or war.
In recent years, the stock markets generally have experienced extreme price and volume fluctuations that have often been
unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors may
significantly affect the market price of our common stock, regardless of our actual operating performance.
In addition, in the past, class action litigation has often been instituted against companies whose securities have
experienced periods of volatility in market price. Securities litigation brought against us following volatility in our stock
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price, regardless of the merit or ultimate results of such litigation, could result in substantial costs, which would hurt our
financial condition and operating results and divert management’s attention and resources from our business.
We do not intend to pay cash dividends on our common stock for the foreseeable future.
We currently anticipate that we will retain future earnings for the development, operation and expansion of our business
and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, the agreement
governing our credit facility precludes, and any future debt agreements may preclude us from paying cash dividends. Any
future determination to declare dividends will be made at the discretion of our board of directors and will depend on,
among other factors, our financial condition, operating results, capital requirements, general business conditions and other
factors that our board of directors may deem relevant. Any return to stockholders will therefore be limited to the
appreciation in the value of their stock, if any.
Our directors, officers and principal stockholders have significant voting power and may take actions that may not be in
the best interests of our other stockholders.
Our officers, directors and principal stockholders each holding more than 5% of our common stock, collectively, control
approximately 46% of our outstanding common stock. As a result, these stockholders, if they act together, will be able to
significantly influence our management and affairs and most matters requiring stockholder approval, including the election
of directors and approval of significant corporate transactions. The interests of these stockholders may not be the same as
or may even conflict with your interests. For example, these stockholders could attempt to delay or prevent a change in
control, even if such change in control would benefit our other stockholders, which could deprive our stockholders of an
opportunity to receive a premium for their common stock as part of a sale of our capital stock or our assets, and might
affect the prevailing market price of our common stock due to investors’ perceptions that conflicts of interest may exist or
arise. As a result, this concentration of ownership may not be in the best interests of our other stockholders.
We are an emerging growth company and the reduced disclosure requirements applicable to emerging growth
companies may make our common stock less attractive to investors.
We are an emerging growth company, as defined in the JOBS Act, and we may take advantage of certain exemptions and
relief from various reporting requirements that are applicable to other public companies that are not “emerging growth
companies.” In particular, while we are an “emerging growth company” (i) we will not be required to comply with the
auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, (ii) we will be exempt from any rules that
could be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotations or a
supplement to the auditor’s report on financial statements, (iii) we will be subject to reduced disclosure obligations
regarding executive compensation in our periodic reports and proxy statements, and (iv) we will not be required to hold
nonbinding advisory votes on executive compensation or stockholder approval of any golden parachute payments not
previously approved.
We may remain an emerging growth company until as late as December 31, 2024, the fiscal year-end following the fifth
anniversary of the completion of our IPO, though we may cease to be an “emerging growth company” earlier under certain
circumstances, including if (i) we have more than $1.235 billion in annual revenue in any fiscal year, (ii) the market value
of our common stock that is held by non-affiliates exceeds $700 million as of any June 30 or (iii) we issue more than
$1.0 billion of non-convertible debt over a three-year period.
The exact implications of the JOBS Act are still subject to interpretations and guidance by the SEC and other regulatory
agencies, and we cannot assure you that we will be able to take advantage of all of the benefits of the JOBS Act. In
addition, investors may find our common stock less attractive to the extent we rely on the exemptions and relief granted by
the JOBS Act. If some investors find our common stock less attractive as a result, there may be a less active trading market
for our common stock and our stock price may decline or become more volatile.
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We are at risk of securities class action litigation.
In the past, securities class action litigation has often been brought against a company following a decline in the market
price of its securities. This risk is especially relevant for us because medical device companies have experienced significant
stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of
management’s attention and resources, which could harm our business.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our
business, our stock price and trading volume could decline.
The trading market for our common stock depends in part on the research and reports that industry or financial analysts
publish about us or our business. If one or more of the analysts who cover us downgrade our stock or publish inaccurate or
unfavorable research about our business, the price of our stock could decline. If one or more of these analysts cease
coverage of us or fail to publish reports covering us regularly, we could lose visibility in the market, which in turn could
cause our stock price to decline.
Provisions in our corporate charter documents and under Delaware law could discourage another company from
acquiring us and may prevent attempts by our stockholders to replace or remove our current management.
Provisions in our fourth amended and restated certificate of incorporation and our third amended and restated bylaws may
discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider
favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These
provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock,
thereby depressing the market price of our common stock. In addition, these provisions may frustrate or prevent any
attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to
replace members of our board of directors. As our board of directors is responsible for appointing the members of our
management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our
management team. These provisions provide, among other things, that:
● our board of directors has the exclusive right to expand the size of our board of directors and to elect
directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or
removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;
● our board of directors is divided into three classes, Class I, Class II and Class III, with each class serving
staggered three-year terms, which may delay the ability of stockholders to change the membership of a
majority of our board of directors;
● our stockholders may not act by written consent, which forces stockholder action to be taken at an annual or
special meeting of our stockholders;
● a special meeting of stockholders may be called only by the chair of our board of directors, our chief
executive officer (or president, in the absence of a chief executive officer) or a majority of our board of
directors, which may delay the ability of our stockholders to force consideration of a proposal or to take
action, including the removal of directors;
● our fourth amended and restated certificate of incorporation prohibits cumulative voting in the election of
directors, which limits the ability of minority stockholders to elect director candidates;
● our board of directors may alter certain provisions of our third amended and restated bylaws without
obtaining stockholder approval;
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● the approval of the holders of at least two-thirds of our shares entitled to vote at an election of our board of
directors is required to adopt, amend or repeal our third amended and restated bylaws or repeal the provisions
of our fourth amended and restated certificate of incorporation regarding the election and removal of
directors;
● stockholders must provide advance notice and additional disclosures to nominate individuals for election to
the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may
discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own
slate of directors or otherwise attempting to obtain voting control of our shares; and
● our board of directors is authorized to issue shares of preferred stock and to determine the terms of those
shares, including preferences and voting rights, without stockholder approval, which could be used to
significantly dilute the ownership of a hostile acquirer.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General
Corporation Law of the State of Delaware (“DGCL”) which prohibits a person who owns in excess of 15% of our
outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in
which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved
in a prescribed manner.
Our fourth amended and restated certificate of incorporation provides that the Court of Chancery of the State of
Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit
our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our fourth amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware
(or, if the Court of Chancery does not have jurisdiction, the United State District Court for the District of Delaware) is the
exclusive forum, to the fullest extent permitted by law, for (i) any derivative action or proceeding brought on our behalf,
(ii) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers,
employees or agents to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the
DGCL or our fourth amended and restated certificate of incorporation or third amended and restated bylaws or (iv) any
action asserting a claim governed by the internal affairs doctrine, except, in each case, (A) any claim as to which such court
determines that there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does
not consent to the personal jurisdiction of such court within 10 days following such determination), (B) which is vested in
the exclusive jurisdiction of a court or forum other than such court, or (C) for which such court does not have subject
matter jurisdiction, in all cases subject to the courts having jurisdiction over indispensable parties named as defendants.
This provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with
us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers
and other employees. For example, stockholders who do bring a claim in the Court of Chancery could face additional
litigations costs in pursuing any such claim, particularly if they do not reside in or near the State of Delaware. The Court of
Chancery may also reach different judgments or results than would other courts, including courts where a stockholder
considering an action may be located or would otherwise choose to bring the action, and such judgments or results may be
more favorable to us than to our stockholders. The enforceability of similar choice of forum provisions in other companies’
certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any
applicable action brought against us, a court could find the choice of forum provisions contained in our fourth amended and
restated certificate of incorporation to be inapplicable or unenforceable in such action. Alternatively, if a court were to find
the choice of forum provision contained in our fourth amended and restated certificate of incorporation to be inapplicable
or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions.
This provision will not apply to actions arising under the Securities Act or Exchange Act. Our fourth amended and restated
certificate of incorporation and third amended and restated bylaws further provide that the federal district courts of the U.S.
will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act.
Section 22 of the Securities Act, however, creates concurrent jurisdiction for federal and state courts over all suits brought
to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. Accordingly, there is
uncertainty as to whether a
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court would enforce such a forum selection provision as written in connection with claims arising under the Securities Act.
General Risk Factors
Our ability to maintain our competitive position depends on our ability to attract and retain senior management and
other highly qualified personnel.
We are highly dependent on our senior management and other key personnel. Our success depends in part on our continued
ability to attract, retain and motivate highly qualified senior management and attract, retain and motivate qualified
employees, including sales and marketing professionals, clinical specialists and other highly skilled personnel. Competition
for skilled personnel in our market is intense and may limit our ability to hire and retain highly qualified personnel on
acceptable terms, or at all. If we are not successful in attracting and retaining highly qualified personnel, it would have a
material adverse effect on our business, financial condition and results of operations. The loss of highly qualified
employees could result in delays in product development and commercialization and harm our business.
Although we have entered into employment agreements with all of our executive officers, each of them may terminate their
employment with us at any time. The replacement of any of our key personnel likely would involve significant time and
costs and may significantly delay or prevent the achievement of our business objectives and could therefore have an
adverse effect on our business. We also do not maintain “key man” insurance policies on the lives of these individuals or
the lives of any of our other employees.
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
We are subject to the periodic reporting requirements of the Exchange Act. We designed our disclosure controls and
procedures to provide reasonable assurance that information we must disclose in reports we file or submit under the
Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported
within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures,
no matter how well those controls and procedures are conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can
occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the
inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.
ITEM 1B.
UNRESOLVED STAFF COMMENTS
None.
ITEM 1C.
CYBERSECURITY
Cyber Risk Management and Strategy
Under the oversight of our board of directors and the Audit Committee of the board, we have adopted cybersecurity risk
management processes that take a risk based approach to assessing, identifying, and managing risks from cybersecurity
threats. Management of cybersecurity risks is part of our overall risk management strategy.
We engage third-party service providers to assist us with our cybersecurity risk management, including for network
monitoring, antivirus protection, and managing IT environments. We have also engaged third party advisors and
consultants to conduct periodic testing of our processes and systems. Before contracting with certain third parties, such as
those that have access to our IT networks, we have a process to conduct diligence on those third parties, which includes a
security assessment. We have also implemented a process for employees to undergo cybersecurity training during
onboarding, and thereafter, on an annual basis as part of our larger compliance training program.
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We have established monitoring procedures in our effort to mitigate risks related to cybersecurity incidents. As part of our
cybersecurity risk management, we have adopted a business continuity and incident response plan, which is designed to
establish our processes for identifying and responding to significant events that may lead to a business disruption or crisis,
including those arising from or related to cybersecurity threats.
Governance
Our board of directors holds oversight responsibility over our strategy and risk management, including risks related to
cybersecurity. The board’s oversight of cybersecurity risk management is supported by the Audit Committee, which has
responsibility for discussing with management significant cybersecurity risks and the measures we have implemented to
monitor and control such cyber risk exposures. The Audit Committee receives quarterly updates from our Vice President,
Information Technology & Compliance (“IT Officer”) relating to IT and cybersecurity matters, including cybersecurity
risks and threats. The Audit Committee provides periodic updates to our board of directors on cybersecurity matters
discussed at such meetings. Our IT Officer also provides these and similar reports to the full board of directors on a
biannual basis.
Our IT Officer oversees the day-to-day management of the Company’s cybersecurity risk management program. Our IT
Officer has over 15 years of experience in IT leadership, and has managed IT for our company for approximately 10 years.
Our IT Officer reports to our Chief Operating Officer and Chief Financial Officer and is a member of our Compliance
Committee. Our IT Officer coordinates with our legal department and relevant third parties, such as consultants and
external legal advisors, to assess and manage material risks from cybersecurity threats. Our IT Officer is also supported by
a cross-functional incident response team, which is empowered to review, assess, report, monitor and take action to
mitigate or remedy any cybersecurity incidents pursuant to our business continuity and incident response plan. Our IT
department further supports and has dedicated resources to assist our IT Officer in monitoring, preventing, detecting,
mitigating, and remediating any cybersecurity incidents pursuant to our policies and procedures.
We have also established a Disclosure Committee, which regularly reviews relevant information related to potential public
disclosure of critical business risks and material events.
We have not identified any cybersecurity incidents or threats that have materially affected us or are reasonably likely to
materially affect us, including our business strategy, results of operations, or financial condition. However, like other
companies in our industry, we and our third-party vendors have from time to time experienced threats and security
incidents that could affect our information or systems. For more information, please refer to Item 1A, “Risk Factors,” in
this Form 10-K.
ITEM 2.
PROPERTIES
Our products are manufactured by our exclusive manufacturer and supplier of our products, Aroa, at their facility in
Auckland, New Zealand which currently totals approximately 40,000 square feet.
We lease our corporate headquarters in Malvern, Pennsylvania, which houses our research and development operations,
controlled environment room, and office space, and currently totals approximately 41,000 square feet.
We believe that our current facilities meet our current and future anticipated needs, although we may seek to negotiate new
leases or evaluate additional or alternate space for our operations. We believe appropriate office space will be readily
available on commercially reasonable terms.
ITEM 3.
LEGAL PROCEEDINGS
We may be subject to other legal proceedings and claims in the ordinary course of business. We cannot predict the results
of any such disputes, and despite the potential outcomes, the existence thereof may have an adverse material impact on us
due to diversion of management time and attention as well as the financial costs related to resolving such disputes.
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ITEM 4.
MINE SAFETY DISCLOSURES
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our common stock has been publicly traded on the Nasdaq Global Market under the symbol “TELA” since November 8,
2019.
Holders
As of March 14, 2024, the Company had approximately 64 record holders of its common stock.
Dividends
The Company has not declared or paid any dividends since its inception nor does it expect to pay dividends in the
foreseeable future.
Securities Authorized for Issuance Under Equity Compensation Plans
The information under the heading “Securities Authorized for Issuance Under Equity Compensation Plans” will be filed in
the Company’s definitive proxy statement for the 2024 annual meeting of stockholders and is incorporated herein by
reference.
Recent Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
None.
ITEM 6.
RESERVED
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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations and the
consolidated financial statements and the related notes included elsewhere in this Annual Report. In addition to historical
financial information, the following discussion contains forward-looking statements based upon our current plans,
expectations and beliefs that involve risks, uncertainties and assumptions. Our actual results may differ materially from
those described in or implied by these forward-looking statements as a result of many factors, including those set forth
under the section titled “Risk Factors” and in other parts of this Annual Report.
Overview
We are a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction
solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy. Our
growing product portfolio is purposefully designed to leverage the patient’s natural healing response while minimizing
long-term exposure to permanent synthetic materials. We are committed to delivering our advanced technologies with a
strong economic value proposition to assist surgeons and institutions in providing next-generation soft-tissue repair
solutions to more patients worldwide.
We are dedicated to building true partnerships with surgeons and healthcare providers to deliver solutions that provide both
clinical and economic improvements. We believe that genuine collaboration with surgeons and healthcare providers results
in the development of new solutions that empower patient care.
Our first portfolio of products, the OviTex Reinforced Tissue Matrix (“OviTex”), which we first commercialized in the
U.S. in July 2016 and in Europe in February 2019, addresses unmet needs in hernia repair and abdominal wall
reconstruction by combining the benefits of biologic matrices and polymer materials while minimizing their shortcomings,
at a cost-effective price.
Hernia repair is one of the most common surgeries performed in the U.S., representing approximately 1.1 million
procedures annually. Based on the volume weighted average selling price of our OviTex products, we estimate the annual
U.S. total addressable market opportunity for our OviTex products to be approximately $1.5 billion.
Our OviTex portfolio consists of multiple product configurations intended to address various surgical procedures within
hernia repair and abdominal wall reconstruction, including ventral, inguinal, and hiatal hernia repair. In addition, we have
also designed an OviTex product specifically for use in laparoscopic and robotic-assisted hernia repair, which we market as
OviTex LPR and began commercializing this product in November 2018. In February 2023, we launched two new, larger
configurations of OviTex LPR, designed for ventral and incisional hernias. More recently, we have designed a set of
OviTex products specifically for use in the inguinal hernia repair (“IHR”), which we expect to launch in the second quarter
of 2024.
We have also focused on evaluating and publishing clinical data on the effectiveness and safety of our OviTex products. To
date, there have been over thirty published or presented works relating to these clinical findings, either by us or a third-
party evaluating the OviTex product. In October 2022, the 24-month results of our single arm, multicenter post-market
clinical study, which we refer to as our BRAVO study, were published in the Annals of Medicine and Surgery. The BRAVO
study was designed to evaluate the clinical performance of OviTex for primary or recurrent ventral hernias using open,
laparoscopic, or robotic techniques in 92 enrolled patients. The recurrence rate at the 24-month time point was 2.6%, and
surgical site occurrences (“SSOs”) were observed in 38% of the study population. Of the enrolled patients, 78% were
characterized as high risk for experiencing an SSO based on at least one known risk factor, which included obesity, active
smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years). The results also indicated that
BRAVO patients experienced statistically significant and clinically meaningful improvements in their quality of life and
perceived health based on patient responses to the EuroQol-5 Dimension (EQ-5D) health assessment and the validated 12-
question Hernia-Related Quality of Life survey (HerQLes). In addition to the BRAVO study and other current clinical
initiatives, we also commenced enrollment in May 2021 for our BRAVO II study, a prospective study evaluating the use of
OviTex in robot-assisted ventral and inguinal hernia repairs.
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Our second portfolio of products, the OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), which we first
commercialized in the U.S. in May 2019, addresses unmet needs in plastic and reconstructive surgery. OviTex PRS is
indicated for use in implantation to reinforce soft-tissue where weakness exists in patients requiring soft-tissue repair or
reinforcement in plastic and reconstructive surgery. Our OviTex PRS portfolio consists of three product configurations with
two or three layers of high-quality tissue derived from ovine rumen, which is reinforced with either permanent or
resorbable polymer for added strength, stabilization, and controlled stretch. These products are designed to improve
outcomes by facilitating functional tissue remodeling while controlling the degree and direction of stretch. In August 2023,
we announced the launch of our OviTex PRS Long-Term Resorbable product configuration, which was designed to
enhance the OviTex PRS portfolio with specific design features including bi-directional stretch and a fully resorbable,
long-term polymer for reinforcement.
Our OviTex PRS portfolio is supported by non-human primate data that demonstrated more rapid tissue integration and
tissue remodeling compared to the market leading biologic matrix used in this indication. Based on the current sales of
biologic matrices in the U.S., we estimate the annual U.S. current addressable market opportunity for our OviTex PRS
products to be approximately $700 million.
Our OviTex products have received 510(k) clearances from the U.S. Food and Drug Administration (“FDA”), which
clearances were obtained and are currently held by our exclusive contract manufacturer of these products, Aroa. In April
2019, our first OviTex PRS products received 510(k) clearance from the FDA, which clearance was initially obtained by
Aroa and is currently held by us. In March 2023, we received an additional 510(k) clearance for our OviTex PRS Long-
Term Resorbable device, which is currently held by us. We have also engaged in discussions with the FDA regarding an
Investigational Device Exemption (“IDE”) protocol to study the safety and effectiveness of our OviTex PRS product for an
indication in breast reconstruction surgery. The FDA has stated that a premarket approval, rather than 510(k) clearance will
be required for such an indication. We have also commenced a retrospective clinical study evaluating the effectiveness and
safety of our OviTex PRS products.
We also continue to expand our service offerings and diversify our supplier base as we continue to create a soft tissue
preservation and restoration portfolio, including through the development of complimentary solutions in our indications
such as atraumatic mesh fixation devices or surgical wound management and infection control. In September 2023, we
entered into a distribution agreement with Advanced Medical Solutions Limited, a company registered in England, to be
their exclusive distributor of their LiquiFix Hernia Mesh Fixation Devices (LiquiFix FIX8™ and LiquiFix Precision™). In
March 2024, we announced the full commercial launch of LiquiFix in the U.S. We previously co-developed and
commercialized our NIVIS Fibrillar Collagen Pack (“NIVIS”), an absorbent matrix of Type I and Type III bovine collagen
designed to manage moderately to heavily exudating wounds and to control minor bleeding, in partnership with Regenity
Biosciences. In March 2024, we sold our distribution rights to MiMedx Group, Inc. in exchange for an initial $5.0 million
payment and additional future payments aggregating between a minimum of $3.0 million and a maximum of $7.0 million
based on net sales of NIVIS over the next two years. We continue to assess additional strategic partnerships with medical
device companies whereby we may enter into distribution, product development and/or licensing agreements for new
products complimentary to, or related to, existing and future products in our distribution channel.
We have a broad portfolio of intellectual property protecting our products that we believe, when combined with the
proprietary manufacturing processes associated with our products and our know-how, provides significant barriers to entry.
Our intellectual property applies to our differentiated product construction and materials. In addition, we believe our
exclusive manufacturing and long-term supply and license agreement (the “Aroa License”) with Aroa creates a competitive
advantage by allowing us to secure an exclusive supply of ovine rumen at a low cost. Ovine rumen, the forestomach of a
sheep, is the source of the biologic material used in our OviTex and OviTex PRS products. We use biologic material from
ovine rumen because of its plentiful supply, optimal biomechanical profile and open collagen architecture that allows for
rapid cellular infiltration. Our OviTex products are manufactured by Aroa at their FDA registered and ISO 13485
compliant facility in Auckland, New Zealand. We purchase product from Aroa at a fixed transfer cost as a percentage of
Aroa’s cost of goods sold, and, with the exception of our recent IHR-dedicated products equals 27% of our net sales of
licensed products. This revenue sharing arrangement allows us to competitively price our products and pass along cost-
savings to our customers.
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We market our products through a single direct sales force, predominantly in the U.S., as augmented by a smaller number
of sales representatives and distributors in certain European countries. We have invested in our direct sales and marketing
infrastructure to expand our presence and to promote awareness and adoption of our products. As of December 31, 2023,
we had 91 sales territories in the U.S. As part of our commercial strategy, we plan to continue to invest in our commercial
organization by hiring additional territory managers and administrative and field-based support employees to support and
service new accounts for soft-tissue reconstruction procedures. We believe we can enhance the productivity of our sales
force by improving customer segmentation and targeting, implementing and further refining our proprietary training
programs, leveraging support from our medical education and medical affairs functions to drive physician awareness,
education and clinical understanding of our products, and utilizing engagement analytics to support further product
development and enhancement opportunities. Additionally, we have contracted with three national group purchasing
organizations (“GPOs”) covering our OviTex and OviTex PRS products and plan to continue to contract with additional
GPOs and other integrated delivery networks (“IDNs”) to increase access to and penetration of hospital accounts.
We are currently devoting research and development resources to develop additional variations of our OviTex and OviTex
PRS product lines, including the additional IHR configurations to further enhance product compatibility in robotic
procedures, larger versions of our current product configurations, the development of configurations with longer-acting
resorbable polymers and other potential product and packaging enhancements to extend the shelf life of our products. In
addition, we also continue to explore the development of lower-cost, higher-margin resorbable polymer-based devices
targeting our current indications. We are also exploring additional technologies that may complement our existing products,
or expand the number of our product lines, in each case within the hernia, plastic and reconstruction, and broader soft-
tissue reconstruction and preservation markets. We intend to continue to make investments in research and development
efforts to develop improvements and enhancements to our product portfolio. We are also assessing strategic partnerships
with medical device companies whereby we may enter into distribution, product development and/or licensing agreements
for products complimentary to, or related to, existing and future products in our distribution channel, which could result in
the payment by us of single digit percentage royalties or other product acquisition costs.
Our business was directly impacted by the COVID-19 pandemic. We experienced volatility in demand for our products
which primarily resulted from government and hospital restrictions, as well as patient health and safety concerns,
decreasing the volume of elective procedures using our products. While procedure volumes have continued to normalize to
pre-pandemic levels, we continue to monitor any lingering economic effects on labor and hospital staffing levels,
procedural volumes and ultimately on our results.
Our revenue for the years ended December 31, 2023 and 2022 was $58.5 million and $41.4 million, respectively, which
represents an increase of $17.0 million, or 41% for the year ended December 31, 2023. Our net loss for the same time
periods was $46.7 million and $44.3 million, respectively, which represents an increase of $2.4 million, or 5% for the year
ended December 31, 2023. As of December 31, 2023, we had an accumulated deficit of $320.9 million. The vast majority
of our revenue to date has been generated from sales of our OviTex and OviTex PRS products in the U.S., with the
remainder generated from sales of our OviTex products in Europe and the sale of other products.
Business Update Regarding Macroeconomic Conditions
Our business, results of operations and commercial operations have been impacted by macroeconomic conditions,
including the COVID-19 pandemic, as well as, to a lesser extent, inflationary pressures, fluctuations in foreign currency in
the jurisdictions in which we operate, banking instability and geopolitical conflicts. These factors have and may continue to
impact us in the following ways:
COVID-19: Our business was directly impacted by the COVID-19 pandemic, including due to government restrictions on
elective procedures and surgical staffing challenges that lead to the deferral of elective surgeries and lower surgical
procedural volumes overall. We believe that surgical procedures have started to normalize to pre-pandemic levels and that
hospital systems have begun to address any remaining backlog of procedures previously delayed due to the COVID-19
pandemic. Additionally, the true economic effects of COVID-19 pandemic may have created other labor and financial
strains on healthcare systems that continue to reduce procedural volumes.
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General Economic Uncertainty: Continued concerns about the systemic impact of a potential economic downturn or
recession, increasing interest rates, further economic downturn or banking instability and geopolitical issues, including the
ongoing Russia-Ukraine conflict and the current conflict in Israel and Gaza (including any escalation or expansion), have
contributed to increased market volatility and diminished expectations for economic growth in the world. As a result, we
have experienced high volatility in our stock price over the prior year. Continued uncertainty, perception of worsening
market conditions and the introduction of new products which may, or may be perceived to, negatively impact the demand
for our products now or in the future could result in a decline in our stock price, high inflation, an increase in our cost of
capital and an adverse effect on our ability to access the capital markets in the future on terms acceptable to us or at all.
Financial Strain: Market acceptance of our medical products in the U.S. and other countries is dependent upon the
procurement practices of our customers, patient need for our products and procedures and the reimbursement of patients’
medical expenses by government healthcare programs and third-party payors. The continuing uncertainty surrounding
macroeconomic conditions and financial markets, including the financial strain suffered by hospital customers during the
COVID-19 pandemic, may adversely affect demand for our products and procedures and result in lower reimbursement
rates or coverage for our products, resulting in lower sales volume and downward pricing pressure on our products and
slower adoption of new products.
Components of Our Results of Operations
Revenue
Substantially all our revenue consists of direct sales of our products to hospital accounts in the U.S. Depending on the
terms of our agreements with our customers, we recognize revenue related to product sales when control transfers, which
generally occurs when the product is shipped to the customer, or when the product is utilized in a surgical procedure in the
case of consignment agreements. Fees charged to customers for shipping are recognized as revenue. Recent revenue
growth has been driven by increasing revenue from product sales due to our expanding customer base, although
macroeconomic pressures described in this Annual Report may impair our ability to continue to generate revenue and
expand our customer base at historic rates.
Cost of Revenue
Cost of revenue primarily consists of the costs of licensed products, charges related to excess and obsolete inventory
adjustments, royalties and costs related to shipping. We purchase product from Aroa at a fixed transfer cost as a percentage
of Aroa’s cost of goods, which, with the exception of our recent IHR-dedicated products, equals 27% of our net sales of
licensed products. The initial term of our Aroa License terminates on the expiration of the last patent covering bovine and
ovine products, with an option to extend for an additional ten-year period. We expect our cost of revenue to increase in
absolute dollars as, and to the extent, our sales volume grows. Any delay in volume growth, whether due to
macroeconomic pressures or otherwise, could lead to additional charges to excess and obsolete inventory.
Amortization of Intangible Assets
Amortization of intangible assets relates to the amortization of capitalized milestone amounts paid to Aroa related to
license fees or commercialization rights after future economic benefit has been established for a product. These capitalized
milestone amounts relate to regulatory clearances, the receipt of certain supply quantities of product, and amounts based
upon aggregate net sales thresholds within a specified territory, and are amortized over the remaining useful life of the
intellectual property.
Gross Profit and Gross Margin
Our gross profit is calculated by subtracting our cost of revenue and amortization of intangible assets from our revenue. We
calculate our gross margin percentage as our gross profit divided by our revenue. Our gross margin has been, and we
expect it will continue to be, affected by a variety of factors, including sales volume, royalties and inventory excess and
obsolescence costs. Our gross profit may increase to the extent our revenue grows.
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Sales and Marketing Expenses
Sales and marketing expenses consist of commercial activities related to the sale of our products, along with the salaries
and related benefits, including sales commissions and stock-based compensation for employees focused on these efforts.
Other significant sales and marketing expenses include costs incurred with post-market clinical studies, conferences and
trade shows, promotional and marketing activities, market research, as well as travel and training expenses.
Over time we expect our sales and marketing expenses to increase in absolute dollars as we continue to expand our
commercial organization to both drive and support our planned growth in revenue. We expect our sales and marketing
expenses to continue to decrease as a percentage of revenue, as and to the extent, our revenue grows.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation
for personnel in executive, finance, information technology and administrative functions. General and administrative
expenses also include professional service fees for legal, accounting, consulting, investor and public relations, insurance
costs and direct and allocated facility-related costs.
We expect that our general and administrative expenses will increase in absolute dollars as we execute our growth
initiatives and expand our business and headcount to support these initiatives. We expect our general and administrative
expenses to decrease as a percentage of revenue primarily as, and to the extent, our revenue grows.
Research and Development Expenses
Research and development expenses consist primarily of product research, engineering, product development, regulatory
compliance and clinical development. These expenses include salaries and related benefits including stock-based
compensation, for employees focused on these efforts, consulting services, costs associated with our preclinical studies,
costs incurred with our manufacturing partner under development agreements related to technology transfer, costs incurred
from license agreements with no alternative future uses, laboratory materials and supplies and an allocation of related
facilities costs. We expense research and development costs as they are incurred.
We expect research and development expenses in absolute dollars to increase in the future as we develop new products and
enhance existing products. We expect research and development expenses as a percentage of revenue to vary over time
depending on the level and timing of new product development initiatives.
Interest Expense
Interest expense consists of cash interest under our credit facilities and non-cash interest attributable to the amortization of
final payment fees and the amortization of deferred financing costs related to our indebtedness.
Loss on Extinguishment of Debt
Loss on extinguishment of debt consists of the excess consideration paid over the net carrying value of our debt at the time
of extinguishment.
Other Income (Expense)
Other income (expense) consists primarily of income earned on our cash and cash equivalents offset by miscellaneous tax
expenses and foreign currency exchange gains and losses.
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Results of Operations
Comparison of the Year Ended December 31, 2023 and 2022
Revenue
Cost of revenue (excluding amortization of intangible assets)
Amortization of intangible assets
Gross profit
Gross margin
Operating expenses:
Sales and marketing
General and administrative
Research and development
Total operating expenses
Loss from operations
Other expense:
Interest expense
Loss on extinguishment of debt
Other income (expense)
Total other expense
Net loss
Revenue
Year Ended December 31,
Change
2023
2022
Dollar
Percentage
$ 58,453
17,961
380
40,112
$ 41,418
13,570
804
27,044
$ 17,035
4,391
(424)
13,068
69 %
65 %
59,681
14,887
9,619
84,187
(44,075)
43,252
13,862
8,937
66,051
(39,007)
(5,223)
—
2,634
(2,589)
(4,051)
(1,228)
(10)
(5,289)
$ (46,664) $ (44,296)
16,429
1,025
682
18,136
(5,068)
(1,172)
1,228
2,644
2,700
$ (2,368)
41 %
32
(53)
48
38
7
8
27
13
29
(100)
NA
(51)
5 %
Revenue increased by $17.0 million, or 41%, to $58.5 million for the year ended December 31, 2023 from $41.4 million
for the year ended December 31, 2022. The increase in revenue was primarily driven by an increase in unit sales of our
products due to the ongoing expansion of our commercial organization, which resulted in the addition of new customers,
increased penetration within existing customer accounts and growing international sales. During the year ended December
31, 2023, we sold 13,675 units of OviTex compared to 10,083 units of OviTex during the year ended December 31, 2022, a
36% increase in unit sales volume. Additionally, we sold 3,544 units of OviTex PRS compared to 2,385 units during the
year ended December 31, 2022, a 49% increase in unit sales volume.
Cost of Revenue
Cost of revenue (excluding amortization of intangible assets) increased by $4.4 million, or 32%, to $18.0 million for the
year ended December 31, 2023 from $13.6 million for the year ended December 31, 2022. The increase in cost of revenue
was primarily the result of an increase in products purchased to support demand from our higher unit sales, partially offset
by a lower charge for excess and obsolete inventory.
Amortization of Intangible Assets
Amortization of intangible assets decreased by $0.4 million, or 53%, to $0.4 million for the year ended December 31, 2023
from $0.8 million for the year ended December 31, 2022. In June 2022, we determined that our final milestone target under
our licensing agreement with Aroa was probable of being met and recorded the payment obligation as an intangible asset,
resulting in an additional amortization charge of $0.5 million.
Gross Margin
Gross margin increased to 69% for the year ended December 31, 2023 from 65% for the year ended December 31, 2022.
The increase was primarily due to lower expense recognized for excess and obsolete inventory adjustments as a
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percentage of revenue which resulted from improved inventory management processes and lower amortization of
intangible assets.
Sales and Marketing
Sales and marketing expenses increased by $16.4 million, or 38%, to $59.7 million for the year ended December 31, 2023
from $43.3 million for the year ended December 31, 2022. The increase was primarily due to higher compensation costs as
a result of the expansion of our commercial organization, increased travel, consulting and marketing expenses and
additional employee-related costs due to an increase in headcount.
General and Administrative
General and administrative expenses increased by $1.0 million, or 7%, to $14.9 million for the year ended December 31,
2023 from $13.9 million for the year ended December 31, 2022. The increase was primarily due to higher compensation
costs and employee-related expenses due to an increase in headcount and increases in professional fees and bad debt
expense, offset by a decrease in insurance expense.
Research and Development
Research and development expenses increased by $0.7 million, or 8%, to $9.6 million for the year ended December 31,
2023 from $8.9 million for the year ended December 31, 2022. The increase was primarily due to higher compensation
costs due to an increase in headcount, offset by lower study costs.
Interest Expense
Interest expense increased by $1.2 million, or 29%, to $5.2 million for the year ended December 31, 2023 from $4.1
million for the year ended December 31, 2022 due to the increased levels of borrowings under our Credit and Security
Agreement (the “MidCap Credit Agreement”) with MidCap Financial Trust, as agent and certain lender parties thereto, and
an increase to the variable component of our interest rate.
Loss on Extinguishment of Debt
We recorded a loss on the extinguishment of debt of $1.2 million during the year ended December 31, 2022 related to the
repayment of borrowings of our credit facilities with OrbiMed. The losses were primarily comprised of the write-off of
unamortized debt discounts and prepayment penalties at the time of extinguishment. No losses were recorded during the
year ended December 31, 2023.
Other Income (Expense)
Other income (expense) increased by $2.6 million primarily due to higher interest income on increased cash balances and
foreign currency translation adjustments.
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Liquidity and Capital Resources
Overview
As of December 31, 2023, we had cash and cash equivalents of $46.7 million, working capital of $54.8 million and an
accumulated deficit of $320.9 million. As of December 31, 2022, we had cash and cash equivalents of $42.0 million,
working capital of $50.0 million and an accumulated deficit of $274.2 million.
In April 2023, we completed an underwritten public offering in which we issued and sold 5,219,190 shares of our common
stock (including 469,190 shares sold pursuant to the underwriters’ overallotment option in May 2023) at a public offering
price of $9.50 per share. We received net proceeds of approximately $46.3 million after deducting underwriting discounts,
commissions and other offering expenses.
In March 2024, we sold our distribution rights to MiMedx Group, Inc. in exchange for an initial $5.0 million payment and
additional future payments aggregating between a minimum of $3.0 million and a maximum of $7.0 million based on net
sales of NIVIS over the next two years.
We have incurred operating losses since our inception, and we anticipate that our operating losses will continue in the near
term as we seek to invest in our sales and marketing initiatives to support our growth in existing and new markets and in
additional research and development activities. As of December 31, 2023, we had $40.0 million of borrowings outstanding
under our Credit and Security Agreement (the “MidCap Credit Agreement”) with MidCap Financial Trust, as agent and
certain lender parties thereto. The MidCap Credit Agreement matures in May 2027 and provides for up to $50.0 million in
term loans (the “MidCap Term Loans”), consisting of a $40.0 million Tranche 1 (“Tranche 1”) and a $10.0 million Tranche
2 (“Tranche 2”). Upon closing, we borrowed $40.0 million of Tranche 1 and used a portion of the proceeds to repay
borrowings under the OrbiMed Credit Facility and intend to use the remaining proceeds to fund operations and other
general corporate purposes. As of December 31, 2023, no additional borrowings were made and our ability to draw from
Tranche 2 has since expired.
Based on our current business plan, we believe that our existing cash resources will be sufficient to meet our capital
requirements and fund our operations for at least the next 12 months from the issuance of this Annual Report. If these
sources are insufficient to satisfy our liquidity requirements, we may seek to sell common or preferred equity or debt
securities or enter into a new credit facility. In November 2023, we entered into a new Equity Distribution Agreement (the
“2023 Equity Agreement”) with Piper Sandler & Co, (“Piper”) in connection with the establishment of an at-the-market
offering program under which we may sell shares of our common stock, from time to time through Piper as sales agent, in
an initial amount of up to $50 million. The 2023 Equity Agreement supersedes and replaces the Company’s previous
Equity Distribution Agreement with the Agent dated December 18, 2020 (the “2020 Equity Agreement”), which is no
longer effective. No sales were made under the 2023 Equity Agreement or the 2020 Equity Agreement during the year
ended December 31, 2023. If we raise additional funds by issuing equity or equity-linked securities, our stockholders
would experience dilution and any new equity securities could have rights, preferences and privileges superior to those of
holders of our common stock. Debt financing, if available, may involve covenants restricting our operations or our ability
to incur additional debt. We cannot be assured that additional equity, equity-linked or debt financing will be available on
terms favorable to us or our stockholders, or at all, including as a result of market volatility stemming from macroeconomic
conditions, including those related to banking instability, increasing interest rates or other factors. If we are unable to obtain
adequate financing, we may be required to delay or reduce the current development, commercialization and marketing
plans for our products.
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Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented:
(in thousands)
Cash used in operating activities
Cash used in investing activities
Cash provided by financing activities
Effect of exchange rate changes on cash and cash equivalents
Net increase (decrease) in cash and cash equivalents and restricted cash
Operating Activities
2023
$ (40,857)
(599)
46,267
164
4,975
Year Ended December 31,
2022
$ (40,748)
(1,872)
40,852
(144)
(1,912)
$
$
$
$
2021
(30,432)
(627)
585
11
(30,463)
During the year ended December 31, 2023, we used $40.9 million of cash in operating activities, resulting from our net loss
of $46.7 million and the change in operating assets and liabilities of $2.0 million, offset by non-cash charges of $7.8
million. Our non-cash charges were comprised of stock-based compensation expense of $5.0 million, our excess and
obsolete inventory charge of $1.4 million, depreciation and amortization expense of $0.8 million and interest expense of
$0.6 million. The change in our operating assets and liabilities was primarily related to increases in accounts receivable and
inventory partially offset by increases in accrued expenses and other current and long-term liabilities.
During the year ended December 31, 2022, we used $40.7 million of cash in operating activities, resulting from our net loss
of $44.3 million and the change in operating assets and liabilities of $5.3 million, offset by non-cash charges of $8.9
million. Our non-cash charges were comprised of stock-based compensation expense of $4.0 million, our excess and
obsolete inventory charge of $1.9 million, loss on extinguishment of debt of $1.2 million, depreciation and amortization
expense of $1.2 million and interest expense of $0.7 million. The change in our operating assets and liabilities was
primarily related to an increase in our inventory and accounts receivable, partially offset by increases in accrued expenses
and other current and long-term liabilities.
During the year ended December 31, 2021, we used $30.4 million of cash in operating activities, resulting from our net loss
of $33.3 million and the change in operating assets and liabilities of $3.5 million, offset by non-cash charges of $6.3
million. Our non-cash charges were comprised of stock-based compensation expense of $3.7 million, our excess and
obsolete inventory charge of $1.4 million, interest expense of $0.7 million and depreciation and amortization expense of
$0.5 million. The change in our operating assets and liabilities was primarily related to an increase in our inventory,
accounts receivable and prepaid expenses and other assets, partially offset by increases in accounts payable and accrued
expenses and other current and long-term liabilities.
Investing Activities
During the year ended December 31, 2023, cash used in investing activities was $0.6 million consisting of purchases of
property and equipment.
During the year ended December 31, 2022, cash used in investing activities was $1.9 million consisting of a $1.0 million
payment made for our intangible asset and purchases of property and equipment.
During the year ended December 31, 2021, cash used in investing activities was $0.6 million consisting of purchases of
property and equipment.
Financing Activities
During the year ended December 31, 2023, cash provided by financing activities was $46.3 million, consisting primarily of
$46.3 million in proceeds received from the sale of our common stock and $0.1 million of proceeds received from the
exercise of stock options partially offset by the payment of withholding taxes related to stock-based compensation to
employees.
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During the year ended December 31, 2022, cash provided by financing activities was $40.9 million, consisting primarily of
$34.4 million in proceeds from an underwritten public offering, $40.0 million in proceeds received from the issuance of
long-term debt, partially offset by $30.0 million in repayments of long-term debt and $3.5 million in payments of issuance
costs.
During the year ended December 31, 2021, cash provided by financing activities was $0.6 million, consisting primarily of
the proceeds received from the exercise of stock options.
Indebtedness
On May 26, 2022, we entered into the MidCap Credit Agreement with MidCap Financial Trust, as agent and certain lender
parties thereto. The MidCap Credit Agreement provides for up to $50.0 million in MidCap Term Loans, consisting of a
$40.0 million Tranche 1 and a $10.0 million Tranche 2. Upon closing, we borrowed $40.0 million of Tranche 1 and used a
portion of the proceeds to fully repay borrowings under the OrbiMed Credit Facility and intend to use the remaining
proceeds to fund operations and other general corporate purposes. As of December 31, 2023, no additional borrowings
were made and our ability to draw from Tranche 2 has since expired.
Pursuant to the MidCap Credit Agreement, we provided a first priority security interest in all existing and future acquired
assets, including intellectual property, owned by us. The MidCap Credit Agreement contains certain covenants that limit
our ability to engage in certain transactions that may be in our long-term best interests, including the incurrence of
additional indebtedness, effecting certain corporate changes, making certain investments, acquisitions or dispositions and
paying dividends.
The MidCap Credit Agreement also contains customary indemnification obligations and customary events of default,
including, among other things, (i) non-payment, (ii) breach of warranty, (iii) non-performance of covenants and
obligations, (iv) default on other indebtedness, (v) judgments, (vi) change of control, (vii) bankruptcy and insolvency, (viii)
impairment of security, (ix) key permit events, (x) termination of a pension plan, (xi) regulatory matters, (xii) material
adverse effect and (xiii) breach of material contracts.
In addition, we must maintain minimum net revenue levels tested quarterly. In the event of default under the MidCap
Credit Agreement, we would be required to pay interest on principal and all other due and unpaid obligations at the current
rate in effect plus 2%.
The MidCap Term Loans mature on May 1, 2027 and bear interest at a rate equal to 6.25% plus the greater of one-month
Term SOFR (as defined in the MidCap Credit Agreement) or 1.0%. We are required to make 36 monthly interest payments
beginning on June 1, 2022 (the “Interest-Only Period”). If we are in covenant compliance at the end of the Interest-Only
Period, we will have the option to extend the Interest-Only Period by 12 months to 48 monthly interest payments, followed
by 12 months of straight-line amortization, with the entire principal payment due at maturity. If we are not in covenant
compliance at the end of the Interest-Only Period, we are required to make 24 months of straight-line amortization
payments, with the entire principal amount due at maturity.
Subject to certain limitations, the MidCap Term Loans have a prepayment fee equal to 3.0% of the prepaid principal
amount for the first year following the closing date of the MidCap Term Loans, 2.0% of the prepaid principal amount for
the second year following the closing date and 1.0% of the prepaid principal amount for the third year following the
closing date and thereafter. We are also required to pay an exit fee at the time of maturity or prepayment event equal to 5%
of all principal borrowings (or in the event of a prepayment event, the amount of principal being prepaid).
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Contractual Obligations and Commitments
The following table summarizes our contractual obligations as of December 31, 2023 and the effects that such obligations
are expected to have on our liquidity and cash flows in future periods:
Payments due by Period
Less than
(in thousands)
Principal payments on long-term debt(1)
Total
$ 40,000
1 year 1 to 3 years 3 to 5 years Thereafter
—
— $ 40,000
— $
$
$
Interest and end of term charge on long-term debt(2)
Operating lease commitments(3)
17,581
3,736
4,677
601
9,354
1,137
3,550
1,153
Purchase commitments
7,080
2,250
4,830
—
—
845
—
Total
$ 68,397
$
7,528
$ 15,321
$ 44,703
$
845
(1) Assumes extension of Interest-Only Period to 48 months under the MidCap Credit Facilty.
(2)
Interest payable reflects the rate in effect as of December 31, 2023. The interest rate on borrowings under the MidCap
Credit Facility is variable and resets monthly. End of term fee reflects final payment fee due at maturity.
(3) Reflects payments due for our lease of office and laboratory space in Malvern, Pennsylvania under an operating lease
agreement that expires in 2030.
ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our cash is held on deposit in demand accounts at high-credit-quality financial institutions in amounts in excess of the
Federal Deposit Insurance Corporation (“FDIC”) insurance coverage limit of $250,000 per depositor, per FDIC-insured
bank, per ownership category. Following the events relating to Silicon Valley Bank in 2023, we established redundant
accounts at high-credit-quality financial institution to mitigate liquidity risk to our cash and cash equivalents from any
further instability in the financial industry. We have reviewed the consolidated financial statements of this financial
institution and believe they have sufficient assets and liquidity to conduct their operations in the ordinary course of
business with little or no credit risk to us.
Financial instruments that potentially subject us to concentrations of credit risk principally consist of cash equivalents and
accounts receivable. We limit our credit risk associated with cash equivalents by placing investments in highly-rated money
market funds. We limit our credit risk with respect to accounts receivable by performing credit evaluations when deemed
necessary, but we do not require collateral to secure amounts owed to us by our customers.
As discussed above in the section of this Annual Report entitled “Liquidity and Capital Resources — Indebtedness,” the
MidCap Credit Facility bears interest at a floating rate of interest, which resets monthly and is equal to 6.25% plus the
greater of one-month Term SOFR or 1.0%. As a result, we are exposed to risks from changes in interest rates. A 1%
increase in interest rates would have resulted in a $0.4 million increase to our interest expense for the year ended December
31, 2023.
Inflationary factors, such as increases in our cost of revenue and operating expenses, may adversely affect our operating
results. Although we do not believe inflation has had a material impact on our financial condition, results of operations or
cash flows to date, a high rate of inflation in the future may have an adverse effect on our ability to maintain and increase
our gross margin or decrease our operating expenses as a percentage of our revenue if our selling prices of our products do
not increase as much or more than our costs increase.
We do not currently have any material exposure to foreign currency fluctuations and do not engage in any hedging
activities as part of our normal course of business.
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Critical Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the U.S.
(“GAAP”). The preparation of our consolidated financial statements and related disclosures requires us to make estimates
and judgments that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at
the date of the consolidated financial statements and the reported amount of revenue and expenses during the reporting
period. We base our estimates on historical experience, known trends and events, and various other factors that we believe
are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an
ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 3 to our consolidated financial statements
appearing elsewhere in this Annual Report, we believe that the following accounting policies are those most critical to the
judgments and estimates used in the preparation of our consolidated financial statements.
Revenue Recognition
We account for revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with
Customers (“ASC 606”). Under ASC 606, we recognize revenue when our customer obtains control of our promised good,
in an amount that reflects the consideration that the entity expects to be entitled in exchange for those goods.
Inventory Valuation
Inventory is stated at the lower of cost or net realizable value, with cost determined using the first-in-first-out method.
Inventory, which consists primarily of our OviTex and OviTex PRS products held on consignment or held in our
warehouse, is considered finished goods and is purchased from a third party.
We evaluate the carrying value of our inventory in relation to the estimated forecast of product demand, which takes into
consideration the expiration date of the products. A significant decrease in demand could result in an increase in the
amount of excess inventory on hand, which could lead to additional charges for excess and obsolete inventory. The need to
maintain substantial levels of inventory impacts our estimates for excess and obsolete inventory. In addition, we continue
to introduce new products and sizes, which we believe will increase our revenue. As a result, we may be required to take
additional charges for excess and obsolete inventory in the future if the purchased units do not align with sales.
Recently Issued and Adopted Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results
of operations is disclosed in Note 3 to our consolidated financial statements appearing elsewhere in this Annual Report.
JOBS Act Accounting Election
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or JOBS Act, and
are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public
companies that are not emerging growth companies. Section 107 of the JOBS Act provides that an emerging growth
company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933
for complying with new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such
time as those standards apply to private companies. Section 107 of the JOBS Act provides that we can elect to opt out of
the extended transition period at any time, which election is irrevocable. We have elected to avail ourselves of this
exemption from complying with new or revised accounting standards and, therefore, will not be subject to the same new or
revised accounting standards as other public companies that are not emerging growth companies.
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ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by this Item is set forth on pages F-1 through F-24 hereto.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, refers to
controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports
that it files or submits under the Exchange Act is recorded, processed, summarized, and reported within the time periods
specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and
procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive
officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. As required
by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our Chief Executive
Officer and Chief Operating Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and
procedures as of the end of the period covered by this Annual Report on Form 10-K. Based on that evaluation, our Chief
Executive Officer and our Chief Operating Officer and Chief Financial Officer concluded that our disclosure controls and
procedures were effective as of December 31, 2023.
Management’s Report on Internal Control Over Financial Reporting
Internal control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive
Officer and Chief Operating Officer and Chief Financial Officer, and effected by our board of directors, management and
other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles, and includes those
policies and procedures that: (1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect
the transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary
to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our
receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (3)
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the
company’s assets that could have a material effect on the financial statements.
Internal control over financial reporting may not prevent or detect all errors and all fraud. A control system, no matter how
well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system
are achieved. Further, the design of a control system must be balanced against resource constraints, and therefore the
benefits of controls must be considered relative to their costs. Given the inherent limitations in all systems of controls, no
evaluation of controls can provide absolute assurance all control issues and instances of fraud, if any, within a company
have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and
that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the
individual acts of some persons, by collusion of two or more people or by management override of the controls. The design
of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can
be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time,
controls may become inadequate because of changes in conditions or the degree of compliance with policies or procedures
may deteriorate. Accordingly, given the inherent limitations in a cost-effective system of internal control, financial
statement misstatements due to error or fraud may occur and may not be detected. Our
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disclosure controls and procedures are designed to provide reasonable, not absolute, assurance of achieving their
objectives. We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies
and procedures.
Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such
term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation
of our management, including our Chief Executive Officer and Chief Operating Officer and Chief Financial Officer, we
conducted an evaluation of the effectiveness of our internal control over financial reporting. Management has used the
framework set forth in the report entitled “Internal Control—Integrated Framework (2013)” published by the Committee of
Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control over financial
reporting. Based on its evaluation, management has concluded that our internal control over financial reporting was
effective as of December 31, 2023.
Changes in Internal Control over Financial Reporting
During the fourth quarter ended December 31, 2023, there were no changes in our internal control over financial reporting
(as defined in Rule 13a-15(f) of the Exchange Act) which materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
Rule 10b5-1 and Non-Rule 10b5-1 Trading Arrangements
During the three months ended December 31, 2023, none of our directors or officers adopted, terminated or modified a
“Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(a) of Regulation S-
K of the Exchange Act.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information concerning directors and compliance with Section 16(a) of the Exchange Act and our Code of Conduct
that applies to our principal executive officer, principal financial officer, principal accounting officer or controller called for
by Item 10 of Form 10-K will be set forth in our definitive proxy statement for the 2024 annual meeting of stockholders, to
be filed within 120 days after the end of the fiscal year covered by this annual report on Form 10-K, and is incorporated
herein by reference.
ITEM 11. EXECUTIVE COMPENSATION
The information required by Item 11 of Form 10-K is incorporated by reference to the information contained in our
definitive proxy statement for the 2024 annual meeting of stockholders.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
The information required by Item 12 of Form 10-K is incorporated by reference to the information contained in our
definitive proxy statement for the 2024 annual meeting of stockholders.
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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The information required by Item 13 of Form 10-K is incorporated by reference to the information contained in our
definitive proxy statement for the 2024 annual meeting of stockholders.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Our independent registered public accounting firm is KPMG LLP, Philadelphia, PA, Auditor Firm ID: 185.
The information required by Item 14 of Form 10-K is incorporated by reference to the information contained in our
definitive proxy statement for the 2024 annual meeting of stockholders.
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) 1. Financial Statements
See Index to the Consolidated Financial Statements on page F-1 of this Annual Report.
2. Financial Statement Schedules
None, as all information required in these schedules is included in the Notes to the Consolidated Financial Statements.
3. Exhibits
Reference is made to the Exhibit Index on page 96 of this Annual Report for a list of exhibits required by Item 601 of
Regulation S-K to be filed as part of this Annual Report.
ITEM 16. FORM 10-K SUMMARY
Not applicable.
95
Table of Contents
TELA Bio, Inc.
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations and Comprehensive Loss
Consolidated Statements of Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
F-1
Page
F-2
F-3
F-4
F-5
F-6
F-7
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors
TELA Bio, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of TELA Bio, Inc. and subsidiary (the Company) as of
December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, stockholders’
equity, and cash flows for each of the years in the three-year period ended December 31, 2023, and the related notes
(collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in
all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its
operations and its cash flows for each of the years in the three-year period ended December 31, 2023, in conformity with
U.S. generally accepted accounting principles.
Change in Accounting Principle
As discussed in Note 3 to the consolidated financial statements, the Company has changed its method of accounting for
leases as of January 1, 2022 due to the adoption of Accounting Standards Update 2016-02, Leases.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to
express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm
registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to 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 and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material
misstatement, 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 financial reporting. As part of our audits, we are required to obtain an understanding of
internal control over financial reporting but not for the purpose of expressing an opinion 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 consolidated financial
statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included
examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our
audits also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable
basis for our opinion.
/s/ KPMG LLP
We have served as the Company’s auditor since 2013.
Philadelphia, Pennsylvania
March 22, 2024
F-2
Table of Contents
TELA Bio, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
Assets
Current assets:
Cash and cash equivalents
Accounts receivable, net of allowances of $416 and $143
Inventory
Prepaid expenses and other assets
Total current assets
Property and equipment, net
Intangible assets, net
Right-of-use assets
Restricted cash
Total assets
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
Accrued expenses and other current liabilities
Total current liabilities
Long‑term debt
Other long‑term liabilities
Total liabilities
Commitments and contingencies (Note 11)
Stockholders’ equity:
$
$
$
December 31,
2023
2022
46,729
9,737
13,162
2,098
71,726
1,984
2,119
1,954
265
78,048
1,667
15,300
16,967
40,515
1,685
59,167
$
$
$
42,019
6,621
11,792
2,015
62,447
1,682
2,499
1,227
—
67,855
1,534
10,869
12,403
39,916
1,231
53,550
Preferred stock; $0.001 par value: 10,000,000 shares authorized; no shares issued and
outstanding
Common stock; $0.001 par value: 200,000,000 shares authorized; 24,494,675 and
19,165,027 shares issued and outstanding at December 31, 2023 and December 31, 2022,
respectively
Additional paid-in capital
Accumulated other comprehensive income
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
—
—
24
339,655
91
(320,889)
18,881
78,048
$
19
288,361
150
(274,225)
14,305
67,855
$
See accompanying notes to consolidated financial statements.
F-3
Table of Contents
TELA Bio, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Revenue
Cost of revenue (excluding amortization of intangible assets)
Amortization of intangible assets
$
Gross profit
Operating expenses:
Sales and marketing
General and administrative
Research and development
Total operating expenses
Loss from operations
Other expense:
Interest expense
Loss on extinguishment of debt
Other income (expense)
Total other expense
Net loss
Net loss per common share, basic and diluted
Weighted average common shares outstanding, basic and diluted
Comprehensive loss:
Net loss
Foreign currency translation adjustment
Comprehensive loss
2023
Year ended December 31,
2022
2021
58,453 $
17,961
380
40,112
59,681
14,887
9,619
84,187
(44,075)
$
41,418
13,570
804
27,044
43,252
13,862
8,937
66,051
(39,007)
29,463
10,346
304
18,813
29,062
12,459
6,743
48,264
(29,451)
(5,223)
—
2,634
(2,589)
(46,664) $
(2.04) $
(4,051)
(1,228)
(10)
(5,289)
$
(44,296)
(2.72)
$
22,868,663 16,267,678
(3,597)
—
(228)
(3,825)
$
(33,276)
(2.30)
$
14,473,213
$
$
(46,664) $
(59)
(46,723) $
(44,296)
202
(44,094)
$
$
(33,276)
19
(33,257)
See accompanying notes to consolidated financial statements.
F-4
Table of Contents
TELA Bio, Inc.
Consolidated Statements of Stockholders’ Equity
(In thousands, except share amounts)
Balance at January 1, 2021
Vesting of common stock previously subject to repurchase
Vesting of share-based awards and exercise of stock options
Issuance of common stock under the employee stock purchase
plan
Foreign currency translation adjustment
Stock‑based compensation expense
Reclassification of liability-classified stock-based compensation
awards
Net loss
Balance at December 31, 2021
Vesting of common stock previously subject to repurchase
Vesting of share-based awards and exercise of stock options
Issuance of common stock under the employee stock purchase
plan
Shares withheld for employee taxes
Foreign currency translation adjustment
Stock‑based compensation expense
Sale of common stock, net of underwriting discounts,
commissions and offering costs
Net loss
Balance at December 31, 2022
Vesting of share-based awards and exercise of stock options
Issuance of common stock under the employee stock purchase
plan
Shares withheld for employee taxes
Foreign currency translation adjustment
Stock‑based compensation expense
Sale of common stock, net of underwriting discounts,
commissions and offering costs
Net loss
Balance at December 31, 2023
$
14,437,107
153
89,154
3,163
—
—
—
—
14,529,577
29
44,346
4,523
(13,448)
—
—
4,600,000
—
19,165,027
126,987
10,602
(27,131)
—
—
Common stock
Shares
Amount
comprehensive Accumulated
income (loss)
Accumulated
other
Additional
paid‑in
capital
245,736
1
546
14
$
—
1
$
—
—
—
—
—
15
—
—
—
—
—
—
4
—
19
—
—
—
—
—
38
—
3,661
82
—
250,064
—
19
50
(157)
—
3,989
34,396
—
288,361
127
88
(289)
—
5,032
(71)
$
—
—
—
19
—
—
—
(52)
—
—
—
—
202
—
—
—
150
—
—
—
(59)
—
deficit
(196,653)
—
—
$
—
—
—
—
(33,276)
(229,929)
—
—
—
—
—
—
—
(44,296)
(274,225)
—
—
—
—
—
Total
49,026
1
547
38
19
3,661
82
(33,276)
20,098
—
19
50
(157)
202
3,989
34,400
(44,296)
14,305
127
88
(289)
(59)
5,032
5,219,190
24,494,675
—
$
5
—
$
24
46,336
—
$
339,655
—
—
$
91
—
(46,664)
(320,889)
$
46,341
(46,664)
18,881
See accompanying notes to consolidated financial statements.
F-5
Table of Contents
TELA Bio, Inc.
Consolidated Statements of Cash Flows
(In thousands)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
Noncash interest expense
Noncash loss on extinguishment of debt
Amortization of intangible assets
Net changes in operating lease ROU assets and liabilities
Inventory excess and obsolescence charge
Stock‑based compensation expense
(Gain) loss on disposal of fixed assets
Change in operating assets and liabilities:
Accounts receivable, net
Inventory
Prepaid expenses and other current assets
Accounts payable
Accrued expenses and other current and long-term liabilities
Foreign currency translation (gain) loss
Net cash used in operating activities
Cash flows from investing activities:
Payment for intangible asset
Purchase of property and equipment
Proceeds from the sale property and equipment
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from sale of common stock, net of underwriting discounts, commissions
and offering costs
Proceeds from issuance of long‑term debt
Repayment of long‑term debt
Payment of debt financing costs
Proceeds from exercise of stock options
Payment of withholding taxes related to stock-based compensation to employees
Proceeds from issuance of common stock under the employee stock purchase plan
Net cash provided by financing activities
Effect of exchange rate on cash and cash equivalents
Net increase (decrease) in cash and cash equivalents and restricted cash
Cash and cash equivalents and restricted cash, beginning of year
Cash and cash equivalents and restricted cash, end of year
Supplemental disclosure of cash flow information:
Cash paid during the period for interest
Supplemental disclosures of noncash investing and financing activities:
Property and equipment in accounts payable and accrued expenses and other current
liabilities
Issuance of common stock for early exercised stock options
Reclassification of liability-classified stock-based compensation awards to equity-
classified
Operating lease ROU asset exchanged for operating lease liabilities
Tenant improvement and deferred rent reclassified to operating lease liabilities
Operating lease liabilities assumed for operating lease ROU assets
$
$
$
$
$
$
$
$
2023
Year ended December 31,
2022
2021
$
(46,664)
$
(44,296)
$
(33,276)
428
599
—
380
(49)
1,414
5,032
(12)
(3,058)
(2,718)
(81)
11
4,177
(316)
(40,857)
—
(611)
12
(599)
46,341
—
—
—
127
(289)
88
46,267
164
4,975
42,019
46,994
$
383
657
1,228
804
(36)
1,866
3,989
—
(2,421)
(6,073)
1,216
(884)
2,399
420
(40,748)
(1,000)
(872)
—
(1,872)
34,400
40,000
(30,000)
(3,460)
19
(157)
50
40,852
(144)
(1,912)
43,931
42,019
4,624
$
3,394
$
$
119
$
— $
— $
$
895
— $
— $
7
$
— $
— $
$
$
$
1,376
380
1,756
231
664
—
304
—
1,439
3,661
2
(1,553)
(5,194)
(992)
1,597
2,673
12
(30,432)
—
(627)
—
(627)
—
—
—
—
547
—
38
585
11
(30,463)
74,394
43,931
2,933
166
1
82
—
—
—
See accompanying notes to consolidated financial statements.
F-6
Table of Contents
(1) Background
TELA Bio, Inc.
Notes to Consolidated Financial Statements
TELA Bio, Inc. (the “Company”) was incorporated in the state of Delaware on April 17, 2012 and wholly owns TELA Bio
Limited, a company incorporated in the United Kingdom. The Company is a commercial-stage medical technology
company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by
prioritizing the preservation and restoration of the patient’s own anatomy. OviTex Reinforced Tissue Matrix (“OviTex”),
the Company’s first portfolio of products, addresses unmet needs in hernia repair and abdominal wall reconstruction by
combining the benefits of biologic matrices and polymer materials while minimizing their shortcomings, at a cost-effective
price. OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), the Company’s second portfolio of products, addresses
unmet needs in plastic and reconstructive surgery. The Company’s principal corporate office and research facility is located
in Malvern, Pennsylvania.
The Company has been directly impacted by the COVID-19 pandemic since the onset of the pandemic in 2020. To date,
among other impacts on the Company’s business related to the pandemic, physicians and their patients have been required
by state mandates, or have chosen to, defer elective surgery procedures in which the Company’s products otherwise would
be used. There remains some uncertainty regarding the lingering effects of the COVID-19 pandemic on the Company’s
near-term revenue growth prospects and product development plans due to the volatility in the frequency of surgical
procedures using the Company’s products, including through labor and hospital staffing shortages and the allocation of
hospital resources due to financial strain experienced during the COVID-19 pandemic. While the Company believes that
surgical procedures have started to normalize to pre-pandemic levels and that hospital systems have begun to address any
remaining backlog of procedures previously delayed due to the COVID-19 pandemic, the full extent of the impact of the
COVID-19 pandemic on the Company’s business, results of operations and financial condition, including revenue,
expenses, manufacturing capability, supply chain integrity, staffing availability, research and development costs and
employee-related compensation, will depend on future developments that remain uncertain.
(2) Risks and Liquidity
The Company’s operations to date have focused on commercializing products, developing and acquiring technology and
assets, business planning, raising capital and organization and staffing. The Company has incurred recurring losses and
negative cash flows from operations since inception and has an accumulated deficit of $320.9 million as of December 31,
2023. The Company anticipates incurring additional losses until such time, if ever, it can generate sufficient revenue from
its products to cover its expenses.
In March 2024, the Company sold its distribution rights for NIVIS Fibrillar Collagen Pack to MiMedx Group, Inc. in
exchange for an initial $5.0 million payment and additional future payments aggregating between a minimum of $3.0
million and a maximum of $7.0 million based on net sales of NIVIS over the next two years.
On April 21, 2023, the Company completed an underwritten public offering in which the Company sold 5,219,190 shares
of its common stock (including 469,190 shares sold pursuant to the underwriters’ overallotment option on May 5, 2023) at
a public offering price of $9.50 per share, receiving net proceeds of approximately $46.3 million after deducting
underwriting discounts, commissions and other offering expenses.
The operations of the Company are subject to certain risks and uncertainties including, among others, the uncertainty of
product development, the impact of macroeconomic conditions, including the lingering effects of the COVID-19 pandemic
or other public health crises, general economic uncertainty, including as a result of inflationary pressures and the measures
undertaken by various governments to address them, banking instability, geopolitical factors such as the ongoing Russia-
Ukraine conflict and the current conflict in Israel and Gaza (including any escalation or expansion), technological
uncertainty, commercial acceptance of any developed products, alternative competing technologies, dependence on
collaborative partners, uncertainty regarding patents and proprietary rights, comprehensive government regulations, and
dependence on key personnel.
F-7
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
(3) Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to
GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”)
promulgated by the Financial Accounting Standards Board (“FASB”). The consolidated financial statements include the
accounts of TELA Bio, Inc. and its wholly owned subsidiary TELA Bio Limited. All intercompany accounts and
transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent
liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the
reporting period. The most significant judgments are employed in estimates used to determine the recoverability of the
carrying value of the Company’s inventory. As future events and their effects cannot be determined with precision, actual
results may differ significantly from these estimates.
Segments
Operating segments are defined as components of an enterprise about which separate discrete information is available for
evaluation by the chief operating decision maker (“CODM”), or decision-making group, in deciding how to allocate
resources and in assessing performance. The CODM, who is the Chief Executive Officer, views the Company’s operations
and manages its business in one segment.
Concentration of Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and
cash equivalents. The Company places its cash with high-credit-quality financial institutions and primarily invests in
money market funds. The Company has established guidelines relative to credit ratings and maturities that seek to maintain
safety and liquidity.
Following the events relating to Silicon Valley Bank in 2023, the Company has established additional redundant accounts
with another high-credit-quality financial institution to mitigate liquidity risk to our cash and cash equivalents from any
further instability in the financial industry.
As described in Note 11, the Company has licensed patents and other intellectual property from Aroa Biosurgery Ltd.
(“Aroa”). As part of this agreement, Aroa is also the exclusive contract manufacturer of the Company’s OviTex portfolio of
products. The inability of Aroa to fulfill supply requirements of the Company could materially impact future operating
results. A change in the relationship with Aroa, or an adverse change in their business, could materially impact future
operating results.
Cash and Cash Equivalents
The Company considers cash equivalents to be highly-liquid investments with maturities of three months or less from the
date of purchase. Cash equivalents consist of investments in a money market fund. The Company’s cash and cash
equivalents are carried at fair value.
F-8
Table of Contents
Restricted Cash
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
Restricted cash represents an amount held in an escrow deposit account, securing a letter of credit for the Company’s office
lease.
Inventory
Inventory consists of purchased materials, primarily finished goods and is identified and tracked by lot and stated at the
lower of cost or net realizable value, with cost being determined on a first-in, first-out basis. Inventories consisted of the
following (in thousands):
Finished goods
Raw materials
Total inventory
December 31,
2023
$ 13,102
60
$ 13,162
2022
$ 11,792
—
$ 11,792
The Company periodically analyzes its inventory levels and writes down inventory that has become obsolete or that has a
cost basis in excess of its expected net realizable value based on expected customer demand. As of December 31, 2023 and
2022, the Company had $3.0 million and $2.3 million, respectively, in finished goods consigned to others.
Property and Equipment
Property and equipment are stated at the aggregate cost incurred to acquire and place the asset in service. Expenditures for
routine maintenance and repairs are charged to expense as incurred and costs of improvements and renewals are
capitalized. Depreciation is provided over the estimated useful lives of the assets using the straight-line method.
Intangible Assets
Upfront payments and milestone payments due related to licenses or commercialization rights prior to future economic
benefit being established are recorded as research and development expenses. Milestone payments due related to licenses
or commercialization rights after future economic benefit is established are recorded as intangible assets. In 2023, 2022 and
2021, the Company recorded $0.4 million, $0.8 million and $0.3 million of amortization expense, respectively, related to
intangible assets. At December 31, 2023, the remaining life of intangible assets was 5.6 years. The Company anticipates
recognizing amortization expense of $0.4 million in each of the next five years and $0.1 million thereafter.
Leases
The Company adopted ASU 2016-02, Leases, (“ASU 2016-02”) on January 1, 2022 using the modified retrospective
transition method and elected the transition practical expedients to not reassess lease identification, lease classification and
initial indirect costs related to those leases entered into prior to the date of application. ASU 2016-02 required a lessee to
record a right-of-use (“ROU”) asset and a corresponding lease liability on the balance sheet for all leases with terms longer
than 12 months.
Long-Lived Assets
Long-lived assets, such as property and equipment and intangible assets, are reviewed for impairment whenever events or
changes in circumstances indicate the carrying amount of an asset may not be recoverable. If circumstances require a long-
lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows
F-9
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
expected to be generated by such asset or asset group to its carrying value. If the carrying value of the long-lived asset or
asset group exceeds the undiscounted cash flows, an impairment is recognized to the extent the carrying value exceeds its
fair value. Fair value is determined using various valuation techniques, including discounted cash flow models, quoted
market values, and third-party independent appraisals, as considered necessary. No impairment losses were recognized
during the years ended December 31, 2023, 2022 or 2021.
Debt Issuance Costs
Debt issuance costs incurred in connection with debt (Note 6) are amortized to interest expense over the term of the
respective financing arrangement using the effective-interest method. Debt issuance costs, net of related amortization are
deducted from the carrying amount of the related debt.
Revenue Recognition
Under ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), an entity recognizes revenue when its
customer obtains control of the promised good, in an amount that reflects the consideration that the entity expects to be
entitled in exchange for those goods. The Company performs the following five steps to recognize revenue under ASC
606: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the
transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize
revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue when it is
probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be
transferred to the customer.
A significant portion of the Company’s revenue is generated from product shipped to a customer or from consigned
inventory maintained at hospitals. Revenue from the sale of consigned products is recognized when control is transferred to
the customer, which occurs at the time the product is used in a surgical procedure. For product that is not held on
consignment, the Company recognizes revenue when control transfers to the customer which occurs at the time the product
is shipped or delivered. For all of the Company’s customer contracts, the only identified performance obligation is
providing the product to the customer.
Revenue is recognized at the estimated net sales price which includes estimates of variable consideration. The Company
enters into contracts with certain third-party payors for the payment of rebates with respect to the utilization of its products.
These rebates are based on contractual percentages. The Company estimates and records rebates in the same period the
related revenue is recognized, resulting in a reduction of product revenue.
Payment terms with customers do not exceed one year and, therefore, the Company does not account for a financing
component in its arrangements. There are no incremental costs of obtaining a contract that would rise to or enhance an
asset other than product costs, which are a component of inventory. The Company expenses incremental costs of obtaining
a contract with a customer (e.g., sales commissions) when incurred as the period of benefit is less than one year. Fees
charged to customers for shipping are recognized as revenue.
The following table presents revenue disaggregated (in thousands):
OviTex
OviTex PRS
Other
Total revenue
Year ended December 31,
2023
2022
2021
$
$
39,416
18,736
301
58,453
$
$
28,879
12,431
108
41,418
$
$
22,990
6,473
—
29,463
F-10
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
Sales outside of the U.S. were $6.1 million or 10% of total revenue for the year ended December 31, 2023, $3.2 million or
8% of total revenue for the year ended December 31, 2022 and immaterial for the year ended December 31, 2021.
Research and Development
Research and development costs are charged to expense as incurred and consist primarily of salaries, benefits, and other
related costs, including stock-based compensation for personnel serving in the research and development functions as well
as costs incurred with Aroa under development agreements related to technology transfer, laboratory materials and
supplies. At the end of the reporting period, the Company compares payments made to third-party service providers to the
estimated progress toward completion of the research or development objectives. Such estimates are subject to change as
additional information becomes available. Depending on the timing of payments to the service providers and the progress
that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or
accrued expense relating to these costs. Costs incurred in obtaining patent and other intellectual property licenses or
milestone payments from license agreements for which there are no alternative future uses are charged to expense as
incurred.
Stock-Based Compensation
The Company accounts for stock-based awards in accordance with provisions of ASC Topic 718, Compensation—Stock
Compensation, under which the Company recognizes the grant-date fair value of stock-based awards issued to employees
and nonemployee board members as compensation expense on a straight-line basis over the vesting period of the award
while awards containing a performance condition are recognized as expense when the achievement of the performance
criteria is considered probable. The Company uses the Black-Scholes option pricing model to determine the grant-date fair
value of stock options. The Company estimates forfeitures that it expects will occur and adjusts expense for actual
forfeitures in the periods they occur.
Income Taxes
Income taxes are accounted for under the asset-and-liability method as required by ASC Topic 740, Income Taxes (“ASC
740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss
and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to
taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on
deferred tax assets and liabilities of a change in tax rates is recognized in income in the period corresponding to the
enactment date. Under ASC 740, a valuation allowance is required when it is more likely than not all or some portion of
the deferred tax assets will not be realized through generating sufficient future taxable income.
ASC Subtopic 740-10, Accounting for Uncertainty of Income Taxes (“ASC 740-10”), defines the criterion an individual tax
position must meet for any part of the benefit of the tax position to be recognized in consolidated financial statements
prepared in conformity with GAAP. The Company may recognize the tax benefit from an uncertain tax position only if it is
more likely than not such tax position will be sustained on examination by the taxing authorities, based solely on the
technical merits of the respective tax position. The tax benefits recognized in the consolidated financial statements from
such a tax position should be measured based on the largest benefit having a greater than 50% likelihood of being realized
upon ultimate settlement with the tax authority. In accordance with the disclosure requirements of ASC 740-10, the
Company’s policy on income statement classification of interest and penalties related to income tax obligations is to
include such items as part of income tax expense.
F-11
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
Fair value of financial instruments
Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction among
market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of
significant judgments are made. Additionally, fair value is used on a nonrecurring basis to evaluate assets for impairment or
as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial
instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used
when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and
cash equivalents, accounts receivable, other assets, and accounts payable are shown at cost, which approximates fair value
due to the short-term nature of these instruments. The carrying amount of the Company’s Credit and Security Agreement
approximates fair value due to its variable interest rate.
The Company follows the provisions of ASC Topic 820, Fair Value Measurement, for financial assets and liabilities
measured on a recurring basis. The guidance requires fair value measurements be classified and disclosed in one of the
following three categories:
● Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical,
unrestricted assets or liabilities.
● Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or
indirectly, for substantially the full term of the asset or liabilities.
● Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value
measurement and unobservable (i.e., supported by little or no market activity).
The following fair value hierarchy table presents information about each major category of the Company’s financial assets
and liabilities measured at fair value on a recurring basis (in thousands):
December 31, 2023:
Cash equivalents – money market fund
December 31, 2022:
Cash equivalents – money market fund
Allowance for credit losses
Fair value measurement at reporting date using
Quoted prices in
active markets
for identical
assets
(Level 1)
Significant other
observable
inputs
(Level 2)
Significant
unobservable
inputs
(Level 3)
$
$
41,561
39,010
$
$
— $
— $
—
—
The following table presents a rollforward of the allowance of credit losses (in thousands):
Year ended December 31, 2021
Year ended December 31, 2022
Year ended December 31, 2023
Balance at
Beginning of
Period
Bad Debt
Expense
Recognized
Write-offs of
Uncollectible
Balances
$
$
$
(46)
(52)
(143)
F-12
(12)
(116)
(306)
6
25
33
Balance at
End of Period
(52)
(143)
(416)
$
$
$
Table of Contents
Net loss per share
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
Basic and diluted net loss per common share is determined by dividing net loss by the weighted-average shares of common
stock outstanding during the reporting period. In periods in which the Company reports a net loss, diluted net loss per share
is the same as basic net loss per share since dilutive shares are not assumed to have been issued if their effect is
antidilutive. Therefore, the weighted-average shares used to calculate both basic and diluted loss per share are the same.
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares
outstanding, as they would be antidilutive.
Stock options (including shares subject to repurchase)
Unvested restricted stock units
Common stock warrants
Total
Recently Issued Accounting Pronouncements
2023
2,162,453
907,203
88,556
3,158,212
December 31,
2022
2,071,848
311,991
88,556
2,472,395
2021
1,706,438
163,043
88,556
1,958,037
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS
Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued
subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company
has elected to use this extended transition period for complying with new or revised accounting standards that have
different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging
growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act.
As a result, these consolidated financial statements may not be comparable to companies that comply with the new or
revised accounting pronouncements as of public company effective dates.
In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments, which provides
guidance for recognizing credit losses on financial instruments based on an estimate of current expected credit losses
model. The standard was effective for the Company beginning January 1, 2023, and the adoption of this guidance did not
have a significant impact on the consolidated financial statements and related disclosures.
In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options and Derivatives and
Hedging - Contracts in Entity’s Own Equity (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash
conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s
own equity that are currently accounted for as derivatives because of specific settlement provisions. The new guidance also
modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the
diluted EPS computation. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, including interim
periods within those annual periods. The adoption of this guidance did not have a significant impact on the consolidated
financial statements and related disclosures.
In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segment Disclosures, which expands
public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to
the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and
description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and
assets. This guidance is effective for annual periods beginning after December 15, 2023, and interim periods within annual
periods beginning after December 15, 2024, with early adoption permitted, including adoption in any
F-13
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
interim period. The Company is currently evaluating the expected impact that the standard could have on its consolidated
financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, requiring entities to provide
additional information in the income tax rate reconciliation and additional disclosures about income taxes paid. The new
accounting guidance requires entities to disclose in their rate reconciliation table additional categories of information about
federal, state and foreign income taxes and to provide more details about the reconciling items in some categories if the
items meet a quantitative threshold. This guidance is effective for annual periods beginning after December 15, 2024, and
should be applied prospectively, but entities have the option to apply it retrospectively for each period presented. Early
adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The
Company is currently evaluating the expected impact that the standard could have on its consolidated financial statements
and related disclosures.
(4) Property and Equipment
Property and equipment consisted of the following (in thousands):
Asset description
Lab equipment
Furniture and fixtures
Computer equipment and software
Leasehold improvements
Estimated useful lives
5 Years
5 Years
3 Years
Lesser of useful life or lease term
$
Total
Less accumulated depreciation and
amortization
Property and equipment, net
December 31,
2023
2,883
284
645
2,507
6,319
$
2022
2,635
274
604
2,309
5,822
(4,335)
1,984
$
(4,140)
1,682
$
The cost of property and equipment at both December 31, 2023 and 2022 includes $0.2 million of equipment located at
Aroa. Depreciation expense was $0.4 million, $0.4 million and $0.2 million for the years ended December 31, 2023, 2022
and 2021, respectively.
(5) Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
Compensation and related benefits
Third-party and professional fees
Amounts due to contract manufacturer
Current portion of operating lease liabilities
Research and development expenses
Other
Total accrued expenses and other current liabilities
F-14
December 31,
$
2023
9,216
2,828
2,024
565
140
527
$ 15,300
$
2022
6,420
2,563
1,263
340
137
146
$ 10,869
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
(6) Debt
Long-term debt consisted of the following (in thousands):
MidCap Term Loan
End of term charge
Unamortized end of term charge and issuance costs
Long-term debt
MidCap Term Loan
December 31,
2023
$ 40,000
2,000
(1,485)
$ 40,515
2022
$ 40,000
2,000
(2,084)
$ 39,916
On May 26, 2022, the Company entered into the Credit and Security Agreement (the “MidCap Credit Agreement”) with
MidCap Financial Trust, as agent (the “Agent”), and certain lender parties thereto. The MidCap Credit Agreement provides
for up to $50.0 million in term loans (the “MidCap Term Loans”), consisting of a $40.0 million Tranche 1 (“Tranche 1”)
and a $10.0 million Tranche 2 (“Tranche 2”). Upon closing, the Company borrowed $40.0 million of Tranche 1 and used a
portion of the proceeds to repay borrowings under the OrbiMed Credit Facility (described below) and intends to use the
remaining proceeds to fund operations and other general corporate purposes. As of December 31, 2023, no additional
borrowings were made and the Company’s ability to draw from Tranche 2 has since expired.
Pursuant to the MidCap Credit Agreement, the Company provided a first priority security interest in all existing and future
acquired assets, including intellectual property, owned by the Company. The MidCap Credit Agreement contains certain
covenants that limit the Company’s ability to engage in certain transactions that may be in the Company’s long-term best
interests, including the incurrence of additional indebtedness, effecting certain corporate changes, making certain
investments, acquisitions or dispositions and paying dividends.
The MidCap Credit Agreement also contains customary indemnification obligations and customary events of default,
including, among other things, (i) non-payment, (ii) breach of warranty, (iii) non-performance of covenants and
obligations, (iv) default on other indebtedness, (v) judgments, (vi) change of control, (vii) bankruptcy and insolvency, (viii)
impairment of security, (ix) key permit events, (x) termination of a pension plan, (xi) regulatory matters, (xii) material
adverse effect and (xiii) breach of material contracts.
In addition, the Company must maintain minimum net revenue levels tested quarterly. In the event of default under the
MidCap Credit Agreement, the Company would be required to pay interest on principal and all other due and unpaid
obligations at the current rate in effect plus 2%.
The MidCap Term Loans mature on May 1, 2027 and bear interest at a rate equal to 6.25% plus the greater of one-month
Term SOFR (as defined in the MidCap Credit Agreement) or 1.0%. The Company is required to make 36 monthly interest
payments beginning on June 1, 2022 (the “Interest-Only Period”). If the Company is in covenant compliance at the end of
the Interest-Only Period, the Company will have the option to extend the Interest-Only Period by 12 months to 48 monthly
interest payments, followed by 12 months of straight-line amortization, with the entire principal payment due at maturity. If
the Company is not in covenant compliance at the end of the Interest-Only Period, the Company is required to make 24
months of straight-line amortization payments, with the entire principal amount due at maturity.
Subject to certain limitations, the MidCap Term Loans have a prepayment fee equal to 3.0% of the prepaid principal
amount for the first year following the closing date of the MidCap Term Loans, 2.0% of the prepaid principal amount for
the second year following the closing date and 1.0% of the prepaid principal amount for the third year following the
closing date and thereafter. The Company is also required to pay an exit fee at the time of maturity or prepayment event
equal to 5% of all principal borrowings (the “End of Term Charge”) (or in the event of a prepayment event, the amount
F-15
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
of principal being prepaid). Interest expense associated with the MidCap Credit Facility recorded for the year ended
December 31, 2023 was $5.2 million, of which $0.6 million was related to the amortization of debt issuance costs. Interest
expense associated with the MidCap Credit Facility recorded for the year ended December 31, 2022 was $2.6 million, of
which $0.4 million was related to the amortization of debt issuance costs.
OrbiMed Term Loan
In November 2018, the Company entered into the OrbiMed Credit Facility with OrbiMed, a related party as the lender is
affiliated with a stockholder of the Company, which consisted of up to $35.0 million in term loans (the “OrbiMed Term
Loans”). The OrbiMed Term Loans consisted of two tranches, a $30.0 million Tranche 1 (“First Tranche”) and a
$5.0 million Tranche 2 (“Second Tranche”). In November 2018, the Company borrowed $30.0 million of the First Tranche.
The Company elected not to borrow the Second Tranche prior to its expiration on December 31, 2019. On May 26, 2022,
the Company entered into the MidCap Credit Agreement and upon closing used a portion of the proceeds to repay all
borrowings under the OrbiMed Credit Facility.
The OrbiMed Term Loan bore interest at a rate equal to 7.75% plus the greater of one-month LIBOR or 2.0% until the
aggregate principal, interest and End of Term Charge of $3.0 million were paid with part of the proceeds received from the
MidCap Credit Agreement. As a result of these payments, a $1.2 million loss on extinguishment was recorded during the
year ended December 31, 2022. Interest expense associated with the OrbiMed Credit Facility recorded for the year ended
December 31, 2022 was $1.5 million, of which $0.3 million was related to the amortization of debt issuance costs. Interest
expense associated with the OrbiMed Credit Facility recorded for the year ended December 31, 2021 was $3.6 million, of
which $0.7 million was related to the amortization of debt issuance costs.
(7) Stockholders’ Equity
Public Stock Offerings
In November 2023, the Company entered into a new Equity Distribution Agreement (the “2023 Equity Agreement”) with
Piper Sandler & Co, (“Piper”) in connection with the establishment of an at-the-market offering program under which the
Company may sell shares of its common stock, from time to time through Piper as sales agent, in an initial amount of up to
$50 million. The 2023 Equity Agreement supersedes and replaces the Company’s previous Equity Distribution Agreement
with Piper dated December 18, 2020 (the “2020 Equity Agreement”), which is no longer effective. No sales were made
under the 2023 Equity Agreement or the 2020 Equity Agreement during the years ended December 31, 2023, 2022 or
2021.
In April 2023, the Company completed an underwritten public offering in which the Company issued and sold 5,219,190
shares of its common stock (including 469,190 shares sold pursuant to the underwriters’ overallotment option in May
2023) at a public offering price of $9.50 per share. The Company received net proceeds of approximately $46.3 million
after deducting underwriting discounts, commissions and other offering expenses.
In August 2022, the Company completed an underwritten public offering in which the Company issued and sold 4,600,000
shares of its common stock at a public offering price of $8.00 per share. The Company received net proceeds of $34.4
million after deducting underwriting discounts, commissions and other offering expenses.
F-16
Table of Contents
Warrants
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
The Company had the following warrants outstanding at December 31, 2023:
Common stock warrants
Common stock warrants
(8) Stock-Based Compensation
Outstanding
8,379
80,177
88,556
Exercise
price
28.65
28.65
Expiration
dates
2028
2027
$
The Company has two equity incentive plans: the 2012 Stock Incentive Plan and the Amended and Restated 2019 Equity
Incentive Plan. New awards can only be granted under the Amended and Restated 2019 Equity Incentive Plan (the “Plan”).
At December 31, 2023, 1,138,279 shares of common stock were available for future issuances under the Plan. The Plan is
subject to an annual increase, subject to prior approval by the Company’s board of directors, equal to the lesser of (i)
432,442 shares, (ii) 4% of the shares outstanding on the last day of the immediately preceding fiscal year and (iii) such
smaller number of shares as determined by the board of directors. The Plan provides for the grant of incentive stock
options, nonqualified stock options, restricted stock awards, restricted stock units and/or stock appreciation rights to
employees, directors, and other persons, as determined by the Company’s board of directors. The Company’s stock options
vest based on the terms in each award agreements and generally vest over four years and have a term of 10 years. The
Company estimates forfeitures that it expects will occur and adjusts expense for actual forfeitures in the periods they occur.
The Company measures employee and nonemployee stock-based awards at grant-date fair value and records compensation
expense ratably over the vesting period of the award. The Company recorded stock-based compensation expense in the
following expense categories of its accompanying consolidated statements of operations and comprehensive loss (in
thousands):
Sales and marketing
General and administrative
Research and development
Total stock‑based compensation
2023
Year ended December 31,
2022
2021
$
$
1,824
2,478
730
5,032
$
$
1,373
2,029
587
3,989
$
$
961
1,542
1,158
3,661
F-17
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
The following table summarizes stock option activity for the Plan:
Outstanding at January 1, 2021
Granted
Exercised
Canceled/forfeited
Outstanding at December 31, 2021
Granted
Exercised
Canceled/forfeited
Outstanding at December 31, 2022
Granted
Exercised
Canceled/forfeited
Outstanding at December 31, 2023
Vested and expected to vest at December 31, 2023
Exercisable at December 31, 2023
Number of
shares
Weighted
average exercise
price per share
Weighted
average
remaining
contractual term
(years)
1,498,208
468,000
(77,154)
(182,645)
1,706,409
450,410
(3,563)
(81,408)
2,071,848
212,960
(25,428)
(96,927)
2,162,453
2,131,840
1,606,779
$
$
$
$
$
$
10.87
14.80
7.08
13.08
11.88
10.24
5.51
13.13
11.49
10.50
5.00
11.25
11.48
11.48
11.50
6.26
6.23
5.50
Included in outstanding options at December 31, 2023, were 355,766 stock options granted outside of the Plan. These
grants were made pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq listing rule 5635(c)(4). At
December 31, 2023, the aggregate intrinsic value of both outstanding options and exercisable options was $0.3 million.
The 2012 Stock Incentive Plan provided the holders of stock options an election to early exercise prior to vesting. The
Company had the right, but not the obligation, to repurchase early exercised options without transferring any appreciation
to the employee if the employee terminates employment before the end of the original vesting period. The repurchase price
is the lesser of the original exercise price or the then fair value of the common stock. At December 31, 2022, all early
exercised options had vested.
The following table summarizes activity relating to early exercise of stock options:
Unvested balance at January 1, 2021
Vested
Unvested balance at December 31, 2021
Vested
Unvested balance at December 31, 2022
Number of
shares
182
(153)
29
(29)
—
The weighted average grant-date fair value per share of options granted was $7.19, $6.55 and $8.66 for the years ended
December 31, 2023, 2022 and 2021, respectively. The aggregate intrinsic value of options exercised was $0.1 million,
$16,000 and $0.4 million for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023,
the total unrecognized compensation expense related to unvested employee and nonemployee stock option awards was
$3.5 million, which is expected to be recognized in expense over a weighted-average period of approximately 2.2 years.
F-18
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
Estimating Fair Value of Stock Options
The fair value of each grant of stock options was determined by the Company using the methods and assumptions
discussed below. Certain of these inputs are subjective and generally require judgment to determine.
Expected term – The expected term of stock options represents the weighted average period the stock options are expected
to be outstanding. The Company uses the simplified method for estimating the expected term as provided by the Securities
and Exchange Commission. The simplified method calculates the expected term as the average time to vesting and the
contractual life of the options.
Expected volatility – Due to the Company’s limited operating history and lack of sufficient company-specific historical or
implied volatility, the expected volatility assumption was determined by examining the historical volatilities of a group of
industry peers, including the Company, whose share prices are publicly available.
Risk-free interest rate – The risk-free rate assumption is based on the U.S. Treasury instruments, the terms of which were
consistent with the expected term of the Company’s stock options.
Expected dividend – The Company has not paid and does not intend to pay dividends.
The fair value of each option was estimated on the date of grant using the weighted average assumptions in the table
below:
Expected dividend yield
Expected volatility
Risk‑free interest rate
Expected term (in years)
Restricted Stock Units
Year ended December 31,
2023
—
2021
—
2022
—
74.3 % 69.6 % 63.9 %
3.99 % 2.55 % 0.99 %
6.15
6.15
6.20
The Company has issued service-based and performance-based restricted stock units (“RSUs”). During the year ended
December 31, 2023, the Company granted 479,585 service-based awards at a weighted average grant-date fair value of
$9.89 per RSU. Vesting of the service-based RSUs is based on the terms in each award agreement and is generally over
four years. During the year ended December 31, 2023, the Company granted 250,149 performance-based RSUs at a
weighted average grant-date fair value of $10.95 per RSU. Vesting of these performance-based RSUs is subject to
continued service through 2026 and the achievement of certain performance milestones for fiscal year 2026. The amount of
RSUs that will vest can range from 0% to 110% of the original number of RSUs granted. Expense for the performance-
based RSUs is not recognized until the performance conditions are deemed probable of achievement. The Company did not
record any expense related to the performance-based RSUs during the year ended December 31, 2023.
F-19
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
The following table summarizes restricted stock units for the Plan:
Outstanding at January 1, 2021
Granted
Vested
Canceled/forfeited
Outstanding at December 31, 2021
Granted
Vested
Canceled/forfeited
Outstanding at December 31, 2022
Granted
Vested
Canceled/forfeited
Outstanding at December 31, 2023
Number of
shares
—
194,232
(12,000)
(19,189)
163,043
197,950
(40,783)
(8,219)
311,991
729,734
(101,559)
(32,963)
907,203
Included in outstanding RSUs at December 31, 2023, were 123,250 RSUs granted outside of the Plan. These grants were
made pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq listing rule 5635(c)(4). The weighted
average grant-date fair value per RSU granted was $10.25, $11.21 and $16.57 during the years ended December 31, 2023,
2022 and 2021, respectively. The aggregate intrinsic value of RSUs outstanding was $6.0 million and $3.6 million at
December 31, 2023 and 2022, respectively. The total unrecognized compensation expense at December 31, 2023 related to
RSUs was $4.8 million, which is expected to be recognized in expense over a weighted-average period of approximately
2.9 years.
(9) Employee Benefit Plans
401(k) Defined Contribution Plan
The Company sponsors a 401(k) defined-contribution plan covering all employees. Participants are permitted to contribute
up to 100% of their eligible annual pretax compensation up to an established federal limit on aggregate participant
contributions. Discretionary contributions made by the Company, if any, are determined annually by the board of directors.
Effective January 1, 2020, the Company matched 50% of employees’ contributions up to 6%, subject to a maximum annual
amount. The Company’s contributions were $0.5 million, $0.4 million and $0.3 million for the years ended December 31,
2023, 2022 and 2021, respectively. Participants are immediately vested in their own contributions to the plan and are fully
vested in discretionary profit sharing made by the Company after three years of service.
2019 Employee Stock Purchase Plan
In November 2019, the Company adopted the 2019 Employee Stock Purchase Plan (the “ESPP”). At December 31, 2023,
518,350 shares were available for future issuance under the ESPP. The ESPP is subject to an annual increase, subject to
prior approval by the Company’s board of directors, equal to the least of (i) 107,887 shares of common stock, (ii) 1% of the
shares outstanding on the final day of the immediately preceding calendar year, and (iii) such smaller number of shares as
determined by the board of directors. The ESPP provides the opportunity to purchase the Company’s common stock at a
15% discount to the market price through payroll deductions. As of December 31, 2023, 2022 and 2021, 10,602, 4,523 and
3,163 shares, respectively, have been issued under the ESPP.
F-20
Table of Contents
(10) Income Taxes
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
The Company has incurred losses since inception. Deferred tax assets and liabilities are determined based on the
differences between the financial statement carrying amounts and tax bases of assets and liabilities using enacted tax rates
in effect for years in which differences are expected to reverse.
Significant components of the Company’s deferred tax assets for federal income taxes consisted of the following (in
thousands):
Deferred tax assets
Net operating loss carryforwards
Interest expense carryforward
Research and development credits
Lease liability
Capitalized research and development expenses
Accrued expenses and other
Inventory reserve
Gross deferred tax asset
Deferred tax liabilities
Depreciation and amortization
Right of use asset
Gross deferred tax liability
Net deferred tax asset before valuation allowance
Valuation allowance
Net deferred tax asset
December 31,
2023
2022
$
$
61,427
523
830
557
4,845
3,535
289
72,006
(436)
(484)
(920)
71,086
(71,086)
$
— $
55,091
—
623
387
1,743
2,682
372
60,898
(435)
(302)
(737)
60,161
(60,161)
—
The Company does not have unrecognized tax benefits as of December 31, 2023 and 2022. The Company recognizes
interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
The Company’s net operating loss (“NOL”) carryforwards for federal and state income tax purposes consisted of the
following (in thousands):
NOL carryforwards
Federal
State
December 31,
2023
2022
$ 239,417
196,132
$
212,314
173,472
The NOL carryforwards begin expiring in 2032 for federal purposes and in 2027 for state income tax purposes yet $160.0
million of the federal NOL carryforwards have no expiration. The Company recorded a valuation allowance on the
deferred tax assets as of December 31, 2023 and 2022 because of the uncertainty of their realization. The valuation
allowance increased by $10.9 million and $10.4 million for the years ended December 31, 2023 and 2022, respectively,
mainly due to losses incurred.
Utilization of the net operating losses and general business tax credits carryforwards may be subject to a substantial
limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if changes in ownership of the
company have occurred previously or occur in the future. Ownership changes may limit the amount of net operating losses
and general business tax credits carryforwards that can be utilized annually to offset future taxable income and tax,
respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the
F-21
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
ownership of 5% shareholders in the stock of a corporation by more than 50 percentage points over a three-year period. If
the Company experiences a Section 382 ownership change, the tax benefits related to the NOL carryforwards may be
further limited or lost. The Company has not performed an analysis under Section 382 and cannot predict or otherwise
determine whether there would be any limitation to the amount of net operating losses and general business tax credits
carryforwards that can be utilized.
A reconciliation of income tax benefit at the statutory federal income tax rate and as reflected in the consolidated financial
statements is as follows:
Rate reconciliation
Federal tax benefit at statutory rate
State rate, net of federal benefit
Permanent differences
Research and development
Change in valuation allowance
Other
Total tax provision
Year ended December 31,
2021
2022
2023
(21.0)% (21.0)%
(21.0)%
(3.1)
(3.1)
0.6
0.7
—
(0.4)
23.4
23.4
0.4
0.1
— % — % — %
(3.5)
0.2
0.4
24.2
(0.3)
The Company files income tax returns in the U.S. federal jurisdiction, various state jurisdictions and the United Kingdom.
Tax years 2020 and forward remain open for examination for federal and the Company’s more significant state tax
jurisdictions. Carryforward attributes from prior years may be adjusted upon examination by taxing authorities if used in an
open period.
(11) Commitments and Contingencies
Legal Proceedings
From time to time, the Company may be a party to lawsuits, claims, and other legal proceedings that arise in the ordinary
course of its business. While the outcomes of these matters are uncertain, management does not expect that the ultimate
costs to resolve these matters will have a material adverse effect on the Company’s consolidated financial position, results
of operations, or cash flows.
Agreements with Aroa
In August 2012, the Company entered into a License, Product Development, and Supply Umbrella Agreement (“Aroa
Agreement”) with Aroa. The Aroa Agreement provides the Company a license to patent rights and other intellectual
property related to Aroa’s products and technologies for use in certain indications and expires on the expiration of the last
patent covering the products (currently March 9, 2031). The Company has the right to extend the term of the agreement by
an additional 10 years following the expiration of the last patent covering the products on commercially reasonable terms
to be negotiated by the parties. This agreement initially limited the Company’s license rights to the U.S. but was
subsequently amended in March 2013 to include certain countries in Europe including the United Kingdom and members
of the European Union and certain former Union of Soviet Socialist Republic satellite nations. The Aroa Agreement
required payments aggregating up to $4.0 million upon the achievement of U.S. and European cumulative product sales
targets.
The Company paid $1.0 million to Aroa in 2018 related to one of the cumulative product sales targets and the remaining
$2.0 million in 2019. The Company paid $1.0 million in 2022 related to the sales milestone payments in the European
territory.
F-22
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
Other key terms of the amended Aroa agreement in addition to those disclosed above are as follows:
● The transfer price for product produced by Aroa is 200% of Aroa’s cost of goods sold, or 150% of Aroa’s
cost of goods sold for the Company’s recent products dedicated for use in inguinal hernia repair (“IHR”). The
transfer price and the quarterly true-up amount continued to equal 27% of Company’s net sales of licensed
products, with the exception of the IHR products, where the total amount payable to Aroa will at least equal
the aggregate transfer pricing paid to Aroa for such products during the applicable calendar year.
● Provisions exist for the Company to step in and operate Aroa’s plant if a supply failure occurs and is not
cured within a set timeframe. Under the amended agreement, the criteria for a supply failure was modified to
mean a failure by Aroa to timely supply, during any consecutive 60-day period, at least 75% of the products
ordered by the Company under binding purchase orders. During the period that the Company steps in and
assumes manufacturing responsibility, it shall not be required to purchase product from or pay transfer prices
to Aroa, the annual minimums shall be proportionately reduced to reflect the lack of supply responsibility by
Aroa and the Company shall pay a royalty of 6% of net sales in lieu of 27% of net sales of the licensed
products.
The Company expects to enter into similar milestone-based agreements with its strategic partner for both product territories
and new products in order to expand and extend its product portfolio.
As of December 31, 2023, the Company had $7.1 million in commitments with one supplier to maintain exclusivity rights
over time and $1.8 million in milestone payments related to certain research and development arrangements which are
currently deemed not probable as the timing and likelihood of such payments are not known with certainty.
Employment Agreements
The Company entered into employment agreements with key personnel providing for compensation and severance in
certain circumstances, as defined in the respective employment agreements.
Leases
The Company leases office and laboratory space in Malvern, Pennsylvania under a noncancelable lease (the “Malvern
Lease”). The Malvern Lease, which was concluded to be an operating lease, was amended in October 2023 to extend the
term of the lease from May 2028 to May 2030 (the “Lease Amendment”). Pursuant to the Lease Amendment, the Company
leased an additional 15,881 square feet at the Company’s corporate headquarters which commenced on December 1, 2023
(the “Expansion Premises”) and will relinquish 4,652 square feet of non-contiguous space currently subject to the lease
agreement on June 30, 2025 (the “Relinquished Space”). The Expansion Premises increased the Company’s total leased
square footage in the building from 24,725 square feet to 40,606 square feet, which will be subsequently reduced to 35,954
square feet as of June 30, 2025 following removal of the Relinquished Space. The modification of the lease terms for the
Company’s existing space was not treated as a separate contract; however, the Company notes that the Expansion Premises
is being treated as a new ROU asset. The Lease Amendment required the Company to pay an additional security deposit of
$0.3 million. The Malvern Lease has annual scheduled payment increases and provides the Company with a renewal option
for an additional term of 60 months at the end of the lease term. The Company evaluates renewal options at lease inception
and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms
when classifying leases and measuring lease liabilities. As the Company is not reasonably certain to exercise the renewal
option, the additional 60-month term has been excluded.
F-23
Table of Contents
TELA Bio, Inc.
Notes to Consolidated Financial Statements (continued)
Operating lease leasehold improvements are depreciated over the lesser of the useful lives of the leasehold improvements
or the lease term.
The Company determined that the rate implicit in its lease is not readily determinable, and therefore, the Company uses its
incremental borrowing rate as the discount rate when measuring operating lease liabilities. The incremental borrowing rate
represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to
the lease payments on a collateralized basis over the term of a lease. The Company used an incremental borrowing rate of
11.66% to discount the Malvern Lease payments included in the operating lease liabilities recognized.
The Company recognized $0.3 million of lease cost during both the years ended December 31, 2023 and 2022. Cash paid
for amounts included in the measurement of operating lease liabilities was $0.4 million and $0.3 million for the years
ended December 31, 2023 and 2022, respectively, and these amounts are included in operating activities in the consolidated
statements of cash flows. As of December 31, 2023, the remaining lease term for the Malvern Lease is 6.4 years.
The following table reconciles the undiscounted future minimum lease payments (displayed in aggregate by year) under
non-cancelable operating leases with terms of more than one year to the total operating lease liabilities recognized on the
consolidated balance sheets as of December 31, 2023 (in thousands):
2024
2025
2026
2027
2028
Thereafter
Total undiscounted future minimum lease payments
Less imputed interest
Total operating lease liabilities
$
$
$
601
580
557
570
583
845
3,736
(1,486)
2,250
As of December 31, 2023, $0.6 million representing the current portion of operating lease liabilities is included in accrued
expenses and other current liabilities in the consolidated balance sheets and $1.7 million representing the long-term portion
of operating lease liabilities is included in other long-term liabilities in the consolidated balance sheets.
(12) Subsequent Event
In March 2024, the Company sold its distribution rights for NIVIS Fibrillar Collagen Pack to MiMedx Group, Inc. in
exchange for an initial $5.0 million payment and additional future payments aggregating between a minimum of $3.0
million and a maximum of $7.0 million based on net sales of NIVIS over the next two years.
F-24
Table of Contents
Exhibits.
The following exhibits are being filed herewith:
Exhibit No.
EXHIBIT INDEX
Exhibit
3.1 Fourth Amended and Restated Certificate of Incorporation (incorporated by reference to exhibit 3.1 of the
Company’s Current Report on Form 8-K filed on November 19, 2019).
3.2 Third Amended and Restated Bylaws (incorporated by reference to exhibit 3.1 of the Company’s Report on Form
10-Q filed on November 13, 2023).
4.1 Specimen Common Stock Certificate of the Company (incorporated by reference to exhibit 4.1 to the Company’s
Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
4.2 Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of
1934 (incorporated by reference to exhibit 4.2 to the Company’s Report on Form 10-K, filed on March 30, 2020).
10.1 Form of Indemnification Agreement by and between the Company and its individual directors and officers
(incorporated by reference to exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-
234217), dated November 7, 2019).
10.2 TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.2 to the Company’s
Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.3 Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.3 to the
Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.4 Second Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.4
to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.5 Third Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.5 to
the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.6 Fourth Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.6 to
the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.7 Fifth Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.7 to
the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.8 Form of Incentive Stock Option Agreement pursuant to the 2012 Stock Incentive Plan (incorporated by reference
to exhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7,
2019)
10.9 Form of Nonstatutory Stock Option Agreement pursuant to 2012 Stock Incentive Plan (incorporated by reference
to exhibit 10.9 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7,
2019)
10.10 TELA Bio, Inc. Amended and Restated 2019 Equity Incentive Plan (incorporated by reference to exhibit 10.1 to
the Company’s Current Report on Form 8-K filed on June 8, 2020).
10.11 Form of TELA Bio, Inc. Amended and Restated 2019 Equity Incentive Plan Stock Option Grant Notice and Stock
Option Agreement (incorporated by reference to exhibit 10.1 to the Company’s Report on Form 10-Q, filed on
May 11, 2022).
10.12 Form of TELA Bio, Inc. Amended and Restated 2019 Equity Incentive Plan Restricted Stock Unit Grant Notice
and Restricted Stock Unit Agreement (time-based vesting) (incorporated by reference to exhibit 10.2 to the
Company’s Report on Form 10-Q, filed on May 11, 2022).
10.13 Form of TELA Bio, Inc. Amended and Restated 2019 Equity Incentive Plan Restricted Stock Unit Grant Notice
and Restricted Stock Unit Agreement (performance-based vesting) (incorporated by reference to exhibit 10.13 to
the Company’s Report on Form 10-K, filed on March 23, 2023).
10.14 TELA Bio, Inc. 2019 Employee Stock Purchase Plan (incorporated by reference to exhibit 10.12 to the
Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.15 Amendment No. 1 to TELA Bio, Inc. 2019 Employee Stock Purchase Plan (incorporated by reference to exhibit
10.15 to the Company’s Report on Form 10-K, filed on March 23, 2023).
10.16 Form of TELA Bio, Inc. Inducement Award Agreement for Non-Qualified Stock Option (incorporated by
reference to exhibit 10.16 to the Company’s Report on Form 10-K, filed on March 23, 2023).
10.17 Form of TELA Bio, Inc. Inducement Award Agreement for Restricted Stock Unit (incorporated by reference
to exhibit 10.17 to the Company’s Report on Form 10-K, filed on March 23, 2023).
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Table of Contents
10.18 TELA Bio, Inc. Amended and Restated Non-Employee Director Compensation Policy (filed herewith).
10.19 Amended and Restated Employment Agreement, dated October 25, 2019, by and between the Company and
Antony Koblish (incorporated by reference to exhibit 10.16 to the Company’s Registration Statement on Form S-1
(File No. 333-234217), dated November 7, 2019).
10.20 Employment Agreement, dated January 17, 2020, by and between the Company and Peter Murphy (incorporated
by reference to exhibit 10.26 to the Company’s Report on Form 10-K, filed on March 30, 2020).
10.21 Employment Agreement, dated August 27, 2021, by and between the Company and Roberto Cuca (incorporated
by reference to exhibit 10.1 to the Company’s Report on Form 8-K, filed on September 27, 2021).
10.22 Employment Agreement, dated September 15, 2020, by and between the Company and Paul Talmo (incorporated
by reference to exhibit 10.19 to the Company’s Report on Form 10-K, filed on March 23, 2022).
10.23 Employment Agreement, dated August 3, 2023, by and between the Company and Gregory Firestone
(incorporated by reference to exhibit 10.1 to the Company’s Report on Form 10-Q, filed on August 10, 2023).
10.24 Credit and Security Agreement, dated as of May 26, 2022, by and among TELA Bio, Inc., MidCap
Financial Trust and the lenders from time to time party thereto (incorporated by reference to exhibit 10.1 to
the Company’s Report on Form 8-K, filed on May 31, 2022).
10.25 Amendment No. 1 to Credit and Security Agreement, dated as of October 18, 2023, by and among TELA Bio,
Inc., MidCap Financial Trust and the lenders from time to time party thereto (filed herewith).
10.26* Second Amended and Restated License, Product Development and Supply Umbrella Agreement, dated July 16,
2015, by and between the Company and Aroa Biosurgery Ltd. (incorporated by reference to exhibit 10.23 to the
Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.27* Amendment to Second Amended and Restated License, Product Development and Supply Umbrella
Agreement, dated November 26, 2015, by and between the Company and Aroa Biosurgery Ltd.
(incorporated by reference to exhibit 10.24 to the Company’s Registration Statement on Form S-1 (File No.
333-234217), dated November 7, 2019).
10.28* Amendment to Second Amended and Restated License, Product Development and Supply Umbrella
Agreement, dated January 3, 2019, by and between the Company and Aroa Biosurgery Ltd. (incorporated by
reference to exhibit 10.25 to the Company’s Registration Statement on Form S-1 (File No. 333-234217),
dated November 7, 2019).
10.29* Addendum to the Second Amended and Restated License, Product Development and Supply Umbrella
Agreement, dated August 27, 2019, by and between the Company and Aroa Biosurgery Ltd. (incorporated
by reference to exhibit 10.22 on the Company’s Report on Form 10-K filed on March 30, 2020).
10.30* Addendum to the Second Amended and Restated License, Product Development and Supply Umbrella
Agreement, dated February 15, 2020, by and between the Company and Aroa Biosurgery Ltd. (incorporated
by reference to exhibit 10.2 on the Company’s Report on Form 10-Q filed on May 15, 2020).
10.31* Addendum to the Second Amended and Restated License, Product Development and Supply Umbrella
Agreement, dated August 13, 2020, by and between the Company and Aroa Biosurgery Ltd. (filed herewith).
10.32 Lease between the Company and Liberty Property Limited Partnership, dated January 31, 2013
(incorporated by reference to exhibit 10.26 to the Company’s Registration Statement on Form S-1 (File No.
333-234217), dated November 7, 2019).
10.33 First Amendment to Lease between the Company and Liberty Property Partnership, dated June 19, 2014
(incorporated by reference to exhibit 10.27 to the Company’s Registration Statement on Form S-1 (File No.
333-234217), dated November 7, 2019).
10.34 Second Amendment to Lease between the Company and WPT Land 2 LP (as successor in interest to Liberty
Property Limited Partnership), dated January 17, 2018 (incorporated by reference to exhibit 10.28 to the
Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.35 Third Amendment to Lease between the Company and WPT Land 2 LP (as successor in interest to Liberty
Property Limited Partnership), dated December 22, 2020 (incorporated by reference to exhibit 10.29 to the
Company’s Report on Form 10-K, filed on March 25, 2021).
10.36 Fourth Amendment to Lease between the Company and WPT Land 2 LP (as successor in interest to Liberty
Property Limited Partnership), dated October 18, 2023 (filed herewith).
10.37 Equity Distribution Agreement, dated November 13, 2023 (incorporated by reference to Exhibit 10.2 of the
Company’s Report on Form 10-Q filed on November 13, 2023).
21.1 Subsidiaries of the Registrant (filed herewith).
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Table of Contents
23.1 Consent of KPMG LLP (filed herewith).
31.1 Certification of Chief Executive Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities
Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith).
31.2 Certification of Chief Financial Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange
Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
32.1 Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
32.2 Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
97.1 TELA Bio, Inc. Compensation Recovery Policy (filed herewith).
101 INS Inline XBRL Instance Document (filed herewith).
101 SCH Inline XBRL Taxonomy Extension Schema Document (filed herewith).
101 CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document (filed herewith).
101 DEF Inline XBRL Taxonomy Extension Definition Linkbase Document (filed herewith).
101 LAB Inline XBRL Taxonomy Extension Label Linkbase Document (filed herewith).
101 PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document (filed herewith).
104 Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).
* Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit.
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Table of Contents
Pursuant 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 by the undersigned, thereunto duly authorized.
SIGNATURES
TELA BIO, INC.
By: /s/ ANTONY KOBLISH
Name: Antony Koblish
Title: President, Chief Executive Officer and Director
Date: March 22, 2024
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons
on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ ANTONY KOBLISH
Antony Koblish
President, Chief Executive Officer and Director
(Principal Executive Officer)
March 22, 2024
/s/ ROBERTO CUCA
Roberto Cuca
Chief Operating Officer and Chief Financial Officer
(Principal Financial Officer)
March 22, 2024
/s/ MEGAN SMEYKAL
Megan Smeykal
Chief Accounting Officer and Controller (Principal
Accounting Officer)
March 22, 2024
/s/ DOUG EVANS
Doug Evans
/s/ KURT AZARBARZIN
Kurt Azarbarzin
/s/ VINCE BURGESS
Vince Burgess
/s/ LISA COLLERAN
Lisa Colleran
/s/ FEDERICA O’BRIEN
Federica O’Brien
Chairman, Board of Directors
March 22, 2024
Director
Director
Director
Director
99
March 22, 2024
March 22, 2024
March 22, 2024
March 22, 2024
AMENDED AND RESTATED
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
Exhibit 10.18
Non-employee members of the board of directors (the “Board”) of TELA Bio, Inc. (the “Company”) shall be
eligible to receive cash and equity compensation as set forth in this Amended and Restated Non-Employee Director
Compensation Policy (this “Policy”). The cash and equity compensation described in this Policy shall be paid or granted, as
applicable, automatically and without further action of the Board, to each member of the Board who is not an employee of
the Company or any parent or subsidiary of the Company (each, a “Non-Employee Director”), unless such Non-Employee
Director declines the receipt of such cash or equity compensation by written notice to the Company. This Policy shall
become effective as of January 1, 2024 (the “Effective Time”) and shall remain in effect until it is revised or rescinded by
further action of the Board. This Policy may be amended, modified or terminated by the Board at any time in its sole
discretion. The terms and conditions of this Policy shall supersede any prior cash and/or equity compensation arrangements
for service as a member of the Board between the Company and any of its Non-Employee Directors and between any
subsidiary of the Company and any of its non-employee directors.
(1)
Cash Compensation.
(a)
the Board.
Annual Retainers. Each Non-Employee Director shall receive an annual retainer of $45,000 for service on
(b)
Additional Annual Retainers. In addition, a Non-Employee Director shall receive the following annual
retainers:
(i)
Chairperson of the Board. A Non-Employee Director serving as Chairperson of the Board shall
receive an additional annual retainer of $35,000 for such service.
(ii)
Audit Committee. A Non-Employee Director serving as Chairperson of the Audit Committee shall
receive an additional annual retainer of $20,000 for such service. A Non-Employee Director serving as a member of the
Audit Committee (other than the Chairperson) shall receive an additional annual retainer of $10,000 for such service.
(iii)
Compensation Committee. A Non-Employee Director serving as Chairperson of the Compensation
Committee shall receive an additional annual retainer of $15,000 for such service. A Non-Employee Director serving as a
member of the Compensation Committee (other than the Chairperson) shall receive an additional annual retainer of $7,500
for such service.
(iv)
Nominating and Corporate Governance Committee. A Non-Employee Director serving as
Chairperson of the Nominating and Corporate Governance Committee shall receive an additional annual retainer of $10,000
for such service. A Non-Employee Director serving as a member of the Nominating and Corporate Governance Committee
(other than the Chairperson) shall receive an additional annual retainer of $5,000 for such service.
(c)
Payment of Retainers.
(i)
Timing. The annual retainers described in Sections 1(a) and 1(b) shall be earned on a quarterly basis
based on a calendar quarter and shall be paid by the Company in arrears not later than the fifteenth day following the end of
each calendar quarter.
(ii)
Form. The annual retainers shall be paid in the form of cash; provided that the Board may, in its
discretion, permit a Non-Employee Director to elect to receive any portion of the annual retainer in the form of shares of
common stock of the Company (“Common Stock”) in lieu of cash. If such an election is permitted by the Board and made
by a Non-Employee Director, the number of shares of Common Stock to be paid shall be determined by dividing the portion
of the annual retainer payable in the form of Common Stock by the Fair Market
Value (as defined in the Company’s Amended and Restated 2019 Equity Incentive Plan or any other applicable Company
equity plan then maintained by the Company (such plan, as may be amended from time to time, the “Equity Plan”)) per
share of Common Stock on the date the annual retainer is payable. Shares issued in lieu of cash shall be fully vested and
unrestricted shares of Common Stock. Any election by a Non-Employee Director to receive a portion of the annual retainer
in shares of Common Stock must be made prior to the applicable payment date for such portion of the annual retainer and
pursuant to an election form to be provided by the Company. An election must comply with all rules established from time to
time by the Board, including any insider trading policy or similar policy. A Non-Employee Director may not make an
election pursuant to this Section 1(c)(ii) during a Company blackout period or when the Non-Employee Director is otherwise
in possession of material non-public information.
(iii)
Termination of Service. In the event a Non-Employee Director does not serve as a Non-Employee
Director, or in the applicable positions described in Section 1(b), for an entire calendar quarter, such Non-Employee Director
shall receive a prorated portion of the retainer(s) otherwise payable to such Non-Employee Director for such calendar
quarter pursuant to Section 1(b), with such prorated portion determined by multiplying such otherwise payable retainer(s) by
a fraction, the numerator of which is the number of days during which the Non-Employee Director serves as a Non-
Employee Director or in the applicable positions described in Section 1(b) during the applicable calendar quarter and the
denominator of which is the number of days in the applicable calendar quarter.
Equity Compensation. Non-Employee Directors shall be granted the equity awards described below (collectively,
(2)
the “Awards”). The Awards shall be granted under and shall be subject to the terms and provisions of the Equity Plan and
shall be granted subject to the execution and delivery of award agreements in substantially the forms approved by the Board.
The approval of this Policy by the Board is intended to be effective for all purposes, including for purposes of satisfying
Rule 16b-3(d)(1) of the Securities Exchange Act of 1934, as amended, in respect of each award issued hereunder.
(a)
Initial Awards. Upon a Non-Employee Director’s initial appointment or election to the Board after the
Effective Time, he or she will be granted: (i) an option to purchase 9,300 shares of Common Stock at a per-share exercise
price equal to the closing price per share of Common Stock on the date of such appointment or election (or on the last
preceding trading day, if the date of such appointment or election is not a trading day), and (ii) a restricted stock unit award
with respect to 6,375 shares of Common Stock. The Awards described in this Section 2(a) shall be referred to as “Initial
Awards.”
(b)
Annual Awards. Each Non-Employee Director who serves on the Board as of the date of any annual meeting
of the Company’s stockholders (an “Annual Meeting”) after the Effective Time, and will continue to serve as a Non-
Employee Director immediately following such Annual Meeting, shall be automatically granted on the date of such Annual
Meeting: (i) an option to purchase 6,200 shares of Common Stock at a per-share exercise price equal to the closing price per
share of Common Stock on the date of such Annual Meeting (or on the last preceding trading day, if the date of the Annual
Meeting is not a trading day), and (ii) a restricted stock unit award with respect to 4,250 shares of Common Stock. The
Awards described in this Section 2(b) shall be referred to as “Annual Awards.”
(c)
Vesting of Awards. Awards will vest as follows, in each case subject to the continued service of the grantee
to the Company through the applicable vesting date or event:
(i)
Initial Awards described in Section 2(a)(i) will vest in 36 equal monthly installments, on the
monthly anniversary of the date of grant over the 36 calendar months commencing after the grantee’s initial
appointment or election to the Board.
(ii)
Initial Awards described in Section 2(a)(ii) will vest in three equal annual installments, on the first
three anniversaries of the grantee’s initial appointment or election to the Board.
(iii)
Annual Awards will vest on the earlier of (A) the first anniversary of the date of grant, and (B) the
date of the subsequent Annual Meeting following the date of grant.
(iv)
In addition, any otherwise unvested Awards will vest and become exercisable in full immediately
prior to and contingent upon the occurrence of a Change in Control (as defined in the Equity Plan).
Exhibit 10.25
Execution Version
AMENDMENT NO. 1 TO CREDIT AND SECURITY AGREEMENT
This AMENDMENT NO. 1 TO CREDIT AND SECURITY AGREEMENT (this “Agreement”) is made as October
18, 2023, by and among TELA BIO, INC., a Delaware corporation (“Borrower”), MIDCAP FINANCIAL TRUST, as
Agent (in such capacity, together with its successors and assigns, “Agent”) and the other financial institutions or other
entities from time to time parties to the Credit Agreement referenced below, each as a Lender.
RECITALS
A.
Agent, Lenders and Borrower have entered into that certain Credit and Security Agreement, dated as of May
26, 2022 (as amended, restated, supplemented or otherwise modified prior to the date hereof, the “Existing Credit
Agreement”, and as the same is amended hereby and as it may be further amended, modified, supplemented and restated
from time to time, the “Credit Agreement”), pursuant to which the Lenders have agreed to extend certain financial
accommodations to Borrower in the amounts and manner set forth in the Credit Agreement.
B.
Borrower has requested, and Agent and Lenders constituting at least the Required Lenders have agreed, to
amend certain provisions of the Existing Credit Agreement in accordance with the terms and subject to the conditions set
forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing, the terms and conditions set forth in this Agreement, and
other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Agent, Lenders
constituting at lease Required Lenders and Borrower hereby agree as follows:
1.
Recitals. This Agreement shall constitute a Financing Document and the Recitals and each reference to the
Credit Agreement, unless otherwise expressly noted, will be deemed to reference the Credit Agreement as amended hereby.
Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the Credit Agreement
(including those capitalized terms used in the Recitals hereto).
2.
Amendment to Existing Credit Agreement. Subject to the terms and conditions of this Agreement,
including, without limitation, the conditions to effectiveness set forth in Section 5 below, the Existing Credit Agreement is
hereby amended as follows:
(a)
The definition of “L/C Cash Collateral Account” in Section 1.1 of the Existing Credit Agreement
is hereby amended by deleting “$250,000” where it appears therein and replacing it with “$300,000”; and
(b)
Clause (h) of the definition of “Permitted Contingent Obligations” in Section 1.1 of the Existing
Credit Agreement is hereby amended by deleting “$250,000” where it appears therein and replacing it with “$300,000”.
3.
Representations and Warranties; Reaffirmation of Security Interest. To induce Agent and Lenders to
enter into this Agreement, Borrower hereby confirms that (i) all of the representations and warranties set forth in the Credit
Agreement are true and correct in all material respects (without duplication of any materiality qualifier in the text of such
representation or warranty) with respect to Borrower as of the date hereof except to the extent that any such representation or
warranty relates to a specific date in which case such representation or warranty shall be true and correct as of such earlier
date
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
and (ii) no Default or Event of Default has occurred and is continuing as of the date hereof. Borrower confirms and agrees
that all security interests and Liens granted to Agent continue in full force and effect, and that all Collateral remains free and
clear of any Liens, other than Permitted Liens. Nothing herein is intended to impair or limit the validity, priority or extent of
Agent’s security interests in and Liens on the Collateral. Borrower acknowledges and agrees that the Credit Agreement, the
other Financing Documents and this Agreement constitute the legal, valid and binding obligation of Borrower, and are
enforceable against Borrower in accordance with its terms, except as the enforceability thereof may be limited by
bankruptcy, insolvency or other similar laws relating to the enforcement of creditors’ rights generally and by general
equitable principles.
4.
Costs and Fees. Borrower agrees to promptly pay, or reimburse upon demand for, all reasonable and
documented out-of-pocket costs and expenses of Agent (including, without limitation, the reasonable and documented fees,
costs and expenses of counsel to Agent) in connection with the preparation, negotiation, execution and delivery of this
Agreement and any other Financing Documents or other agreements prepared, negotiated, executed or delivered in
connection with this Agreement.
5.
Conditions to Effectiveness. This Agreement shall become effective as of the date on which each of the
following conditions has been satisfied, as determined by Agent in its sole discretion:
(a)
Agent shall have received a duly authorized, executed and delivered counterpart of the signature
page to this Agreement from Borrower, Agent and Required Lenders;
(b)
Agent shall have received a duly executed copy of the amendment, dated as of the date hereof, to
that certain lease agreement, dated as of January 31, 2013, as amended, among Borrower and WPT Land 2 LP;
(c)
all representations and warranties of Borrower contained herein shall be true and correct in all
material respects (without duplication of any materiality qualifier in the text of such representation or warranty) as of the
date hereof except to the extent that any such representation or warranty relates to a specific date in which case such
representation or warranty shall be true and correct as of such earlier date (and such parties’ delivery of their respective
signatures hereto shall be deemed to be its certification thereof);
(d)
no Default or Event of Default shall exist under any of the Financing Documents immediately prior
to and after giving effect to this Agreement; and
(e)
Borrower shall have delivered such other documents, information, certificates, records, permits, and
filings as the Agent may reasonably request in connection with this Agreement.
6.
Post-Closing Obligations. Borrower hereby covenants and agrees that it shall by the date thirty (30) days
after the date hereof, deliver to Agent an amendment to that certain Landlord’s Lien Subordination agreement dated as of
May 26, 2022, among Agent, Borrower and WPT Land 2 LP, in form and substance reasonably satisfactory to Agent,
amending the definition of the Premises contained in such agreement to include all property leased by Borrower from WPT
Land 2 LP. Borrower agrees that failure to comply with the requirements set forth in this Section 7 shall constitute an
immediate and automatic Event of Default.
7.
Release. In consideration of the agreements of Agent and Lenders contained herein and for other good and
valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Borrower, voluntarily, knowingly,
unconditionally and irrevocably, with specific and express intent, for and on behalf of itself and all of its respective parents,
subsidiaries, affiliates, members, managers, predecessors, successors, and assigns, and each of its respective current and
former directors, officers,
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
2
shareholders, agents, and employees, and each of its respective predecessors, successors, heirs, and assigns (individually and
collectively, the “Releasing Parties”) does hereby fully and completely release, acquit and forever discharge each of Agent,
Lenders, and each their respective parents, subsidiaries, affiliates, members, managers, shareholders, directors, officers and
employees, and each of their respective predecessors, successors, heirs, and assigns (individually and collectively, the
“Released Parties”), of and from any and all actions, causes of action, suits, debts, disputes, damages, claims, obligations,
liabilities, costs, expenses and demands of any kind whatsoever, at law or in equity, whether matured or unmatured,
liquidated or unliquidated, vested or contingent, choate or inchoate, known or unknown that the Releasing Parties (or any of
them) has against the Released Parties or any of them (whether directly or indirectly), based in whole or in part on facts,
whether or not now known, existing on or before the date hereof, that relate to, arise out of or otherwise are in connection
with: (i) any or all of the Financing Documents or transactions contemplated thereby or any actions or omissions in
connection therewith or (ii) any aspect of the dealings or relationships between or among Borrower, on the one hand, and
any or all of the Released Parties, on the other hand, relating to any or all of the documents, transactions, actions or
omissions referenced in clause (i) hereof. Borrower acknowledges that the foregoing release is a material inducement to
Agent’s and each Lender’s decision to enter into this Agreement and agree to the modifications contemplated hereunder, and
has been relied upon by Agent and the Lenders in connection therewith.
8.
No Waiver or Novation. The execution, delivery and effectiveness of this Agreement shall not operate as a
waiver of any right, power or remedy of Agent, nor constitute a waiver of any provision of the Credit Agreement, the
Financing Documents or any other documents, instruments and agreements executed or delivered in connection with any of
the foregoing. Nothing herein is intended or shall be construed as a waiver of any existing Defaults or Events of Default
under the Credit Agreement or the other Financing Documents or any of Agent’s rights and remedies in respect of such
Defaults or Events of Default. This Agreement (together with any other document executed in connection herewith) is not
intended to be, nor shall it be construed as, a novation of the Credit Agreement.
9.
Affirmation. Except as specifically amended pursuant to the terms hereof, Borrower hereby acknowledges
and agrees that the Credit Agreement and all other Financing Documents (and all covenants, terms, conditions and
agreements therein) shall remain in full force and effect, and are hereby ratified and confirmed in all respects by Borrower.
Borrower covenants and agrees to comply with all of the terms, covenants and conditions of the Credit Agreement and the
Financing Documents, notwithstanding any prior course of conduct, waivers, releases or other actions or inactions on
Agent’s or any Lender’s part which might otherwise constitute or be construed as a waiver of or amendment to such terms,
covenants and conditions.
10.
Miscellaneous.
(a)
Reference to the Effect on the Credit Agreement. Upon the effectiveness of this Agreement, each
reference in the Credit Agreement to “this Agreement,” “hereunder,” “hereof,” “herein,” or words of similar import shall
mean and be a reference to the Credit Agreement, as amended by this Agreement. Except as specifically amended above,
the Credit Agreement, and all other Financing Documents (and all covenants, terms, conditions and agreements therein),
shall remain in full force and effect, and are hereby ratified and confirmed in all respects by Borrower.
(b)
GOVERNING LAW. THIS AGREEMENT AND ALL DISPUTES AND OTHER MATTERS
RELATING HERETO OR THERETO OR ARISING THEREFROM (WHETHER SOUNDING IN CONTRACT LAW,
TORT LAW OR OTHERWISE), SHALL BE GOVERNED BY, AND SHALL BE CONSTRUED AND ENFORCED IN
ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK, WITHOUT REGARD TO CONFLICTS OF
LAWS PRINCIPLES (OTHER THAN SECTION 5-1401 OF THE GENERAL OBLIGATIONS LAW).
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
3
(c)
JURY TRIAL. BORROWER, AGENT AND THE LENDERS HEREBY IRREVOCABLY
WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL ACTION OR PROCEEDING ARISING OUT
OF OR RELATING TO THE FINANCING DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED THEREBY
AND AGREES THAT ANY SUCH ACTION OR PROCEEDING SHALL BE TRIED BEFORE A COURT AND NOT
BEFORE A JURY. BORROWER, AGENT AND EACH LENDER ACKNOWLEDGES THAT THIS WAIVER IS A
MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS RELIED ON THE
WAIVER IN ENTERING INTO THIS AGREEMENT AND THE OTHER FINANCING DOCUMENTS, AND THAT
EACH WILL CONTINUE TO RELY ON THIS WAIVER IN THEIR RELATED FUTURE DEALINGS. BORROWER,
AGENT AND EACH LENDER WARRANTS AND REPRESENTS THAT IT HAS HAD THE OPPORTUNITY OF
REVIEWING THIS JURY WAIVER WITH LEGAL COUNSEL, AND THAT IT KNOWINGLY AND VOLUNTARILY
WAIVES ITS JURY TRIAL RIGHTS
(d)
Incorporation of Credit Agreement Provisions. The provisions contained in Section 11.6
(Indemnification), Section 12.9 (Waiver of Jury Trial) and Section 12.14 (Expenses; Indemnity) of the Credit Agreement are
incorporated herein by reference to the same extent as if reproduced herein in their entirety.
(e)
Headings. Section headings in this Agreement are included for convenience of reference only and
shall not constitute a part of this Agreement for any other purpose.
(f)
Counterparts. This Agreement may be signed in any number of counterparts, each of which shall be
deemed an original and all of which when taken together shall constitute one and the same instrument. Delivery of an
executed counterpart of this Agreement by facsimile or by electronic mail delivery of an electronic version (e.g., .pdf or .tif
file) of an executed signature page shall be effective as delivery of an original executed counterpart hereof and shall bind the
parties hereto. In furtherance of the foregoing, the words “execution”, “signed”, “signature”, “delivery” and words of like
import in or relating to any document to be signed in connection with this Agreement and the transactions contemplated
hereby or thereby shall be deemed to include Electronic Signatures, deliveries or the keeping of records in electronic form,
each of which shall be of the same legal effect, validity or enforceability as a manually executed signature, physical delivery
thereof or the use of a paper-based recordkeeping system, as the case may be, to the extent and as provided for in any
applicable law, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State
Electronic Signatures and Records Act, or any other similar state laws based on the Uniform Electronic Transactions Act.
As used herein, “Electronic Signature” means an electronic sound, symbol, or process attached to, or associated with, a
contract or other record and adopted by a Person with the intent to sign, authenticate or accept such contract or other record.
(g)
Entire Agreement. This Agreement constitutes the entire agreement and understanding among the
parties hereto and supersedes any and all prior agreements and understandings, oral or written, relating to the subject matter
hereof.
(h)
Severability. In case any provision of or obligation under this Agreement shall be invalid, illegal or
unenforceable in any applicable jurisdiction, the validity, legality and enforceability of the remaining provisions or
obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected or impaired thereby.
(i)
Successors/Assigns. This Agreement shall bind, and the rights hereunder shall inure to, the
respective successors and assigns of the parties hereto, subject to the provisions of the Credit Agreement and the other
Financing Documents.
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
4
[SIGNATURES APPEAR ON FOLLOWING PAGES]
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
5
IN WITNESS WHEREOF, intending to be legally bound, the undersigned have executed this Agreement as of the
day and year first hereinabove set forth.
AGENT:
MIDCAP FINANCIAL TRUST
Apollo Capital Management, L.P.,
By:
its investment manager
Apollo Capital Management GP, LLC,
By:
its general partner
/s/ Maurice Amsellem
By:
Name: Maurice Amsellem
Title: Authorized Signatory
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
LENDER:
MIDCAP FINANCIAL TRUST
Apollo Capital Management, L.P.,
By:
its investment manager
Apollo Capital Management GP, LLC,
By:
its general partner
/s/ Maurice Amsellem
By:
Name: Maurice Amsellem
Title: Authorized Signatory
LENDER:
MIDCAP FUNDING XIII TRUST
Apollo Capital Management, L.P.,
By:
its investment manager
Apollo Capital Management GP, LLC,
By:
its general partner
/s/ Maurice Amsellem
By:
Name: Maurice Amsellem
Title: Authorized Signatory
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
LENDER:
MIDCAP FINANCIAL INVESTMENT
CORPORATION (formerly known as Apollo
Investment Corporation)
/s/ Kristin Hester
By:
Name:Kristin Hester
Title: Chief Legal Officer
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
LENDER:
LENDER:
ELM 2020-3 TRUST
By: MidCap Financial Services Capital
Management, LLC, as Servicer
/s/ John O’Dea
By:
Name:John O’Dea
Title: Authorized Signatory
ELM 2020-4 TRUST
By: MidCap Financial Services Capital
Management, LLC, as Servicer
/s/ John O’Dea
By:
Name:John O’Dea
Title: Authorized Signatory
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
BORROWER:
TELA BIO, INC.
/s/ Roberto Cuca
By:
Name:Roberto Cuca
Title: Chief Operating Officer and Chief Financial Officer
MidCap / TELA Bio / Amendment No. 1 to Credit Agreement
Exhibit 10.31
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such
excluded information is not material and would likely cause competitive harm to the registrant if publicly
disclosed.
ADDENDUM TO THE SECOND AMENDED AND RESTATED LICENSE,
PRODUCT DEVELOPMENT AND SUPPLY UMBRELLA AGREEMENT
This Addendum to the Second Amended and Restated License, Product Development and Supply Umbrella Agreement (this
“Addendum”), is made as of the 13 day of August, 2020, by and between TELA Bio, Inc. (“TELA Bio”), and Aroa
Biosurgery Limited (“Aroa”), and sets out the terms of TELA Bio's and Aroa's agreement with respect to pricing of/for the
ENDOFORM® PRS PLGA Reconstructive Template (“PRS PLGA Product”).
WHEREAS, TELA Bio and Aroa are parties to that certain Second Amended and Restated License, Product Development
and Supply Umbrella Agreement dated as of July 16, 2015, as amended through the date hereof and which includes the
addenda thereto dated as of September 21, 2017, January 3, 2019, August 27, 2019 and February 21, 2020 (the “Umbrella
Agreement”);
WHEREAS, TELA Bio and Aroa will, effective as of the date of this Addendum, enter into a Development Agreement and
Exhibit 10 for and with respect to the PRS PLGA Product, for the purposes of the Umbrella Agreement; and
WHEREAS, TELA Bio and Aroa desire to amend the Umbrella Agreement in connection with entering into such
Development Agreement and Exhibit 10 for and with respect to the PRS PLGA Product;
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged,
and intending to be legally bound hereby, TELA Bio and Aroa hereby agree as follows:
1. Section 6.1 of the Umbrella Agreement shall be amended by adding the following paragraph at the end of Section 6.1 as
follows:
[***]
Capitalised terms used but not defined in this Addendum have the meanings given to those terms in the Umbrella
Agreement.
Except as agreed herein, the provisions of the Umbrella Agreement (including any prior addenda thereto) are not amended
and continue to be in full force and effect.
This Addendum shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to
any conflict of law provisions.
This Addendum may be executed in separate counterparts, each of which shall be an original and all of which taken together
shall constitute one and the same agreement.
Executed signature pages to this Addendum may be delivered by facsimile or electronic mail and any signature page so
delivered shall be deemed to be an original.
(signature page follows)
IN WITNESS WHEREOF, each of the parties has caused this Addendum to be executed by its duly authorized
representative as of the date first above written.
TELA BIO, INC.
/s/ Antony Koblish
By:
Name: Antony Koblish
Title: President & CEO
AROA BIOSURGERY LIMITED
/s/ Brian Ward
By:
Name: Brian Ward
Title: CEO
Exhibit 10.36
FOURTH AMENDMENT TO LEASE AGREEMENT
THIS FOURTH AMENDMENT TO LEASE AGREEMENT (this “Fourth Amendment”) is made
this 18th day of October, 2023 (the “Effective Date”), by and between WPT LAND 2 LP, a Delaware limited
partnership (“Landlord”), and TELA BIO, INC., a Delaware corporation (“Tenant”).
BACKGROUND:
A.
Landlord (pursuant to that certain Assignment and Assumption of Leases dated October 3, 2016,
described in Section B of the Background section of the Second Amendment (defined below)), and Tenant are
now parties to that certain Lease Agreement dated January 31, 2013 (the “Original Lease”), as amended by that
certain First Amendment to Agreement of Lease dated June 19, 2014 (the “First Amendment”), that certain
Second Amendment to Agreement of Lease dated January 17, 2018 (the “Second Amendment”) and that certain
Third Amendment to Lease Agreement dated December 22, 2020 (the “Third Amendment”, and together with
the Original Lease, the First Amendment, the Second Amendment, and that certain letter from Workspace
Property Trust to Tenant dated January 8, 2019 regarding HVAC management attached as Exhibit B to the Third
Amendment, collectively, the “Existing Lease”, and the Existing Lease, as further amended by this Fourth
Amendment, is the “Lease”), covering certain premises now containing: (i) 11,460 rentable square feet of space
identified as Suite 24 (“Suite 24”); (ii) 4,652 rentable square feet of space identified as Suite 12 (“Suite 12”); and
(iii) 8,613 rentable square feet of space identified as Suite 20 (“Suite 20”, and together with Suite 24 and Suite 12,
hereafter collectively identified as the “Original Premises”, containing in the aggregate, 24,725 rentable square
feet of space), located in Landlord’s 60,880 rentable square foot building identified as One Great Valley Parkway,
Malvern, Pennsylvania 19355 (the “Building”) as more fully described in the Existing Lease.
B.
Tenant desires to amend the Existing Lease providing, among other things, for: (i) the expansion of
the Original Premises by leasing to Tenant certain premises in the Building known as Suite 30, containing 15,881
rentable square feet of space (hereafter, “Suite 30” or the “Expansion Premises”), as more particularly shown on
Exhibit A to this Fourth Amendment, which, when combined with the Original Premises shall contain an
aggregate of 40,606 rentable square feet of space for a period commencing on the Expansion Premises
Commencement Date (as re-defined below) and ending on the Relinquished Space Termination Date (as defined
below); (ii) the reduction of the amount of rentable square feet of the Original Premises leased by Tenant by
vacating Suite 12 (the “Relinquished Space”) as of the Relinquished Space Termination Date, while retaining
Suite 20 and Suite 24 (the “Remaining Space”) and the Expansion Premises, as more particularly shown on
Exhibit A to this Fourth Amendment, which, resulting in an aggregate of 35,954 rentable square feet of space for
a period commencing on the Relinquished Space Termination Date and ending on the last day of the Term; (iii)
the extension of the Term (as re-defined below) applicable to the Remaining Space; (iv) Tenant’s performance of
Expansion Premises Tenant Improvements (as re-defined below); (v) Landlord’s performance of the Roof Repair
Work (as defined below); (vi) the modification of the Security Deposit; and, (vii) the modification of certain other
sections of the Existing Lease, to which the parties hereto have agreed, subject, in each case, to the terms and
provisions of the Existing Lease, as hereby amended.
NOW, THEREFORE, the parties hereto, in consideration of the mutual promises and covenants
contained herein and in the Existing Lease, and intending to be legally bound, hereby agree as follows:
1.
Incorporation. The above Background is incorporated herein by reference as if more fully set
forth below.
2.
Defined Terms; Conflict. All capitalized terms used herein and not otherwise defined herein shall
have the meanings ascribed to such terms in the Existing Lease. In the event there is a conflict between the terms
of the Existing Lease and the terms of this Fourth Amendment, the terms of this Fourth Amendment shall control.
3.
Relinquished Space Termination; Extension of Remaining Space Term; Expansion Premises
Term.
May 31, 2028.
(a)
The Expiration Date of the Term for the Original Premises pursuant to the Existing Lease is
(b)
Subject to the terms and conditions of this Fourth Amendment, the Lease applicable to the
Relinquished Space shall terminate as of June 30, 2025 (the “Relinquished Space Termination Date”). On or
prior to the Relinquished Space Termination Date, except for the existing IT cabling, which shall remain in place,
Tenant shall relinquish to Landlord and vacate the Relinquished Space in its entirety and as required under Section
21(a) of the Original Lease. No early termination fee shall be due to Landlord in connection with the
relinquishment of the Relinquished Space. Tenant’s failure to vacate the Relinquished Space by the Relinquished
Space Termination Date shall be an immediate Event of Default under the Lease, entitling Landlord to exercise all
of the rights and remedies available to Landlord under the Existing Lease including, without limitation,
Landlord’s rights and remedies to treat Tenant as a holdover tenant under Sections 21(b) of the Original Lease.
(c)
Subject to Section 3(d) below, the Term applicable to the Remaining Space is hereby
extended for one (1) period of twenty-four (24) months (hereafter, the “Extended Term”), commencing on June
1, 2028 (hereafter, the “Extended Term Commencement Date”) and expiring at 11:59 p.m. EST on May 31,
2030 (hereafter, the “Expiration Date”).
(d)
Landlord hereby leases to Tenant, and Tenant hereby leases from Landlord, the Expansion
Premises on the same terms and conditions set forth in the Existing Lease, as amended hereby, for a period
commencing on December 1, 2023 (hereafter, the “Expansion Premises Commencement Date”), and expiring at
11:59 P.M. EST on the Expiration Date (hereafter, the “Expansion Premises Term”).
(e)
From and After the Extended Term Commencement Date, the word “Term”, as defined in
the Existing Lease, as amended hereby, shall also include the Extended Term and, from and after the Expansion
Premises Commencement Date, the word “Term”, as defined in the Existing Lease, as amended hereby, shall also
include the Expansion Premises Term.
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(f)
From and after the Expansion Premises Commencement Date and continuing until the
Relinquished Space Termination Date, the term “Premises”, as defined in the Existing Lease, as amended hereby,
shall mean and include both the Original Premises and the Expansion Premises. From and after the Relinquished
Space Termination Date and continuing until the Expiration Date, as hereby amended, the term “Premises”, as
defined in the Existing Lease, as amended hereby, shall mean and include only the Remaining Space and the
Expansion Premises.
4.
Minimum Annual Rent.
(a)
Notwithstanding anything in the Existing Lease or this Fourth Amendment to the contrary,
from and after the Effective Date through the date that is the day immediately prior to the Expansion Premises
Commencement Date, Tenant shall continue to pay the existing monthly Minimum Annual Rent applicable to the
Original Premises as provided in the Third Amendment, which the parties agree is currently Thirty Thousand
Eighty-Two and 08/100 Dollars ($30,082.08) plus all other charges comprising Rent (i.e. Annual Operating
Expenses and any other amounts payable by Tenant to Landlord) pursuant to the Existing Lease, as hereby
amended.
(b)
From and after the Expansion Premises Commencement Date, the rent tables included as
part of Sections 4(b) and 4(c) of the Third Amendment are null and void and of no further force or effect. In lieu
thereof, commencing on the Expansion Premises Commencement Date, and continuing to and including the
Relinquished Space Termination Date, Tenant’s Minimum Annual Rent obligation for the Original Premises and
the Expansion Premises shall be as follows:
Period
December 1, 2023 – May 31, 2024
June 1, 2024 – May 31, 2025
June 1, 2025 – June 30, 2025
$/RSF
$14.60
$14.95
$15.30
Annualized
(based on 40,606 rsf)
-----
$607,059.70
$621,271.80
Monthly
$49,403.97
$50,588.31
$51,772.65
(c)
From and after the Relinquished Space Termination Date, and continuing to and including
Expiration Date, as hereby amended, Tenant’s Minimum Annual Rent obligation for the Remaining Space and the
Expansion Premises shall be as follows:
Period
July 1, 2025 – May 31, 2026
June 1, 2026 – May 31, 2027
June 1, 2027 – May 31, 2028
June 1, 2028 – May 31, 2029
June 1, 2029 – May 31, 2030
$/RSF
$15.30
$15.65
$16.00
$16.35
$16.70
3
Annualized
(based on 35,954 rsf)
-----
$562,680.10
$575,264.00
$587,847.90
$600,431.80
Monthly
$45,841.35
$46,890.01
$47,938.67
$48,987.33
$50,035.98
5.
Tenant’s Share; Annual Operating Expenses. From and after the Effective Date and continuing
until the Expiration Date, as amended hereby and as the same may be extended pursuant to the Existing Lease,
Tenant shall pay Tenant’s Share of Annual Operating Expenses attributable to the Premises in addition to the
Minimum Annual Rent, subject to adjustment and reconciliation in accordance with the terms of the Lease.
(a)
Tenant acknowledges Tenant’s Share of annual Operating Expenses applicable to the
Original Premises is 40.61%, which Tenant shall continue to pay from the Effective Date hereof until the day
immediately prior to the Expansion Premises Commencement Date.
(b)
Tenant hereby acknowledges that, from and after the Expansion Premises Commencement
Date to and including the Relinquished Space Termination Date, “Tenant’s Share” applicable to the Original
Premises and the Expansion Premises shall be increased by virtue of such expansion to 66.70%, calculated by
dividing the rentable square feet of the Original Premises and the Expansion Premises (40,606) by the total
rentable square feet of the Building (60,880).
(c)
Tenant hereby acknowledges that, from and after the Relinquished Space Termination Date
to and including the Expiration Date, as the same may be extended pursuant to the Existing Lease, “Tenant’s
Share” applicable to the Remaining Space and the Expansion Premises shall be decreased by virtue of such
relinquishment to 59.06%, calculated by dividing the rentable square feet of the Remaining Space and the
Expansion Premises (35,954) by the total rentable square feet of the Building (60,880).
6.
Acceptance of the Original Premises; Expansion Premises Work; Landlord’s Roof Repair
Work.
(a)
Tenant currently occupies the Original Premises and has, from the Commencement Date of
the Lease, accepted and hereby certifies, agrees and confirms it accepted the Original Premises in all respects
following Landlord’s delivery of the Original Premises to Tenant, and Landlord’s Work, as such term is defined in
the Second Amendment (the “Current Premises Condition”), and it continues to accept the Original Premises in
such Current Premises Condition, and, except as otherwise provided in the Lease, Landlord shall have no
obligations whatsoever to improve or pay for any improvements to the Original Premises for Tenant’s use and
occupancy thereof during the remainder of the Term, other than with respect to Landlord’s ongoing maintenance,
repair, replacement, and similar obligations as described in the Lease.
(b)
On the Expansion Premises Commencement Date, Tenant will accept the Expansion
Premises in its “as is” “where is” condition, except as described in Section 6(e) below, and Landlord shall have no
obligations whatsoever to improve or pay for any improvements to the Expansion Premises for Tenant’s use and
occupancy thereof during the Expansion Premises Term other than the Expansion Premises Tenant Allowance (as
defined below), Landlord’s Roof Repair Work, and Landlord’s ongoing maintenance, repair, replacement, and
similar obligations as described in the Lease.
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(c)
At any reasonable times after the Effective Date hereof, Landlord shall coordinate with
Tenant to allow Tenant and Tenant’s Agents to access the Expansion Premises for the purpose of conducting
measurements in preparation for the Expansion Premises Tenant Improvements (as re-defined below).
(d)
Following the Effective Date, Tenant intends to make improvements to the Expansion
Premises and the Retained Space. Tenant will have plans for improvements to the Expansion Premises and the
Retained Space designed and approved in accordance with Section 6(d)(i) below (hereafter, the “Tenant
Improvements”) and constructed in accordance with Section 6(d)(ii) below.
(i)
Tenant’s improvement specifications and plans for the Expansion Premises and the
Retained Space shall be prepared by Tenant’s architect and/or engineer, as applicable, to be finally approved by
Landlord. Such plans will be prepared in sufficient detail to permit Tenant or Landlord to construct the Tenant
Improvements. Such plans shall be prepared in accordance with applicable laws and code requirements.
Landlord shall not unreasonably withhold, condition or delay its approval of such plans. Upon approval by
Landlord, such plans shall become final and shall not be changed without Landlord’s further approval, which shall
not be unreasonably withheld, conditioned or delayed (as finally approved, hereafter, the “Tenant Improvement
Plans”). The Tenant Improvement Plans shall not apply to any “cosmetic change” to either the Expansion
Premises or to the Retained Space. For the purposes of this section “cosmetic change” shall mean any change that
does not require a building permit from the appropriate issuing authority. For the avoidance of doubt, Tenant shall,
in its sole discretion, have the right to use or dispose of any trade fixtures, or equipment within the Expansion
Premises.
(ii)
Tenant shall complete the Tenant Improvements to the Expansion Premises in
accordance with the Tenant Improvement Plans and applicable provisions of the Lease, including but not limited
to the provision of insurance, filing of mechanic lien waivers, and delivery of permits to Landlord. The
contractors selected by Tenant for bidding on the Tenant Improvements shall be subject to the approval of
Landlord, which shall not be unreasonably withheld, conditioned or delayed.
(iii)
All construction shall be performed in a good and workmanlike manner and shall
comply at the time of completion with all applicable laws and requirements of the governmental authorities
having jurisdiction. Tenant shall provide a certificate of occupancy (if required by applicable law) to Landlord
upon substantial completion of the work required by the Tenant Improvement Plans.
(iv)
Tenant shall, subject to Section 6(d)(v) below, pay the costs, expenses and fees
incurred for the construction of the Tenant Improvements, including without limitation (1) the cost charged by the
general contractor and all subcontractors for performing such construction, (2) construction permit fees, (3) costs
of built-in furniture, (4) HVAC unit replacements; and (5) other hard costs of construction including built-in
shelving, ceiling tiles, sheetrock ceilings, lighting replacement, installation of accent lighting and/or wall sconces,
demolition of existing sheetrock partitions, painting, carpet and VCT tile, wallcovering, and replacement or
modification of flooring (together, the “Tenant Improvement Costs”).
5
(v)
Landlord shall provide an allowance to Tenant equal to the lesser of (i) the Tenant
Improvement Costs or (ii) $397,025.00 (hereafter, the “Tenant Allowance”). Landlord acknowledges that a
portion of the Tenant Allowance, not to exceed Thirty-Nine Thousand Seven Hundred Two and 50/100 Dollars
($39,702.50) may be applied against Tenant’s design costs applicable to the Tenant Improvements. The remainder
of the Tenant Allowance may only be applied against the hard construction costs and building system
modification costs of the Tenant Improvements. After completion of the Tenant Improvements, Tenant shall
promptly pay all Tenant Improvement Costs, and submit to Landlord the certificate of occupancy, final plans,
invoices, proof of payment of all vendors, and lien releases satisfactory to Landlord, and an invoice for a one-time
reimbursement of the Tenant Improvement Costs up to the limit of the Tenant Allowance (hereafter, collectively,
the “Reimbursement Requirements”). If Tenant fails to complete or comply with all or any of the
Reimbursement Requirements on or prior to the date that is eighteen (18) months following the Expansion
Premises Commencement Date, it shall forfeit the right to receive any of the Tenant Allowance. Tenant shall also
not be entitled to receive any of the Tenant Improvement Allowance if, at the time of requesting same or at any
time prior thereto, Tenant has failed to cure an ongoing default until such default is cured, but only if the cure of
such default by Tenant is permitted under the Lease.
(e)
Promptly following Tenant’s removal from the roof of the Building of the existing
abandoned York HVAC unit and related infrastructure serving the Premises as part of the Tenant Improvements
work, Landlord shall cause Landlord’s roofing contractor to repair and patch the roof of the Building in the
location such HVAC unit was located, at Landlord’s sole cost and expense (and not as an Operating Expense)
(“Landlord’s Roof Repair Work”). All Landlord’s Roof Repair Work shall be done in a good and workmanlike
manner and shall comply with all applicable laws and requirements of governmental authorities having
jurisdiction.
(f)
As of the Effective Date, Landlord hereby represents and warrants to Tenant that Landlord
has not received written notice from (i) any governmental or quasi-governmental body having jurisdiction or (ii)
any other tenant at the Building of any violations of Environmental Law occurring on or about the Property or the
Expansion Premises. Following the Effective Date, Landlord shall provide Tenant with written notice of its
receipt of any written notices from any governmental or quasi-governmental body having jurisdiction of violations
of Environmental Law which require Landlord to conduct remediation of Hazardous Materials at the Premises
(being the Remaining Space and the Expansion Premises. Landlord shall indemnify, defend and hold Tenant
harmless from all claims, demands, actions, liabilities, costs, expenses, attorneys’ fees, damages and obligations
of any nature arising from, or as a result of, any Hazardous Materials at the Expansion Premises that: (i) did not
exist at the Expansion Premises as of the Effective Date of this Fourth Amendment, and (ii) with respect to which
Landlord is required to remediate pursuant to applicable laws. Landlord’s obligations pursuant to this subsection
shall survive the expiration or termination of the Lease.
7.
Security Deposit. As of the Effective Date, Section 27 of the Original Lease and Section 12 of the
Third Amendment are hereby deleted in their entirety and no longer of any further force or effect. In lieu thereof,
the following is substituted. Landlord acknowledges receipt of Tenant’s existing cash Security Deposit in the
amount of Thirty-Three Thousand Nine
6
Hundred Sixty-Six and 19/100 Dollars ($33,966.19) (hereafter, the “Existing Security Deposit”). In addition to
the Existing Security Deposit, on the Effective Date, Tenant shall post an additional security deposit in the amount
of Two Hundred Sixty-Three Thousand Eight Hundred Two and 81/100 Dollars ($263,802.81) (the “Additional
Security Deposit”, and together with the Existing Security Deposit, collectively, the “Security Deposit” in the
aggregate amount of Two Hundred Ninety-Seven Thousand Seven Hundred Sixty-Nine Dollars ($297,769.00)).
The Additional Security Deposit may be provided in cash, by an unconditional irrevocable letter of credit (as
detailed in sections (a)-(i) below) for the benefit of Landlord (a “LOC”), or some combination thereof. Any LOC
utilized by Tenant shall have a term no shorter than ninety (90) days following the Expiration Date of the Lease
(the “Outside LOC Expiration Date”), issued by a federally insured banking institution acceptable to Landlord
in its sole discretion, and subject to this Section 7. Notwithstanding anything set forth herein to the contrary if, as
applicable, (i) no Event of Default has occurred under this Lease, and (ii) no event exists which with the giving of
notice or the passage of time could become an Event of Default under this Lease, promptly after Landlord
receives written notice from Tenant requesting such reduction: (a) on June 1, 2025, the amount of the Security
Deposit shall be reduced to Two Hundred Fifty Thousand Dollars ($250,000); (b) on June 1, 2026, the amount of
the Security Deposit shall be reduced to Two Hundred Thousand Dollars ($200,000); (c) on June 1, 2027, the
amount of the Security Deposit shall be reduced to One Hundred Fifty Thousand Dollars ($150,000); (d) on June
1, 2028, the amount of the Security Deposit shall be reduced to One Hundred Thousand Dollars ($100,000); and
(e) on June 1, 2029, the amount of the Security Deposit shall be reduced to Fifty Thousand Dollars ($50,000). If
at any time after the date hereof Tenant’s LOC is or becomes noncompliant with any of the requirements of this
Section 7, or is terminated prior to the Outside LOC Expiration Date, Tenant shall immediately deposit with
Landlord cash in the then current amount of the LOC, less the Existing Security Deposit currently held in cash by
Landlord to serve as Tenant’s Security Deposit required herein, under and in accordance with the terms and
provisions of this Section 7.
(a)
If Tenant elects to utilize cash to post all, or a portion of the Additional Security Deposit,
Tenant shall issue such amount to Landlord on the Effective Date (the “Cash Component”). If Tenant elects to
utilize a LOC to post all, or a portion of the Additional Security Deposit, on the Effective Date, Tenant shall
deliver to Landlord a LOC from a national or regional banking or financial institution reasonably acceptable to
Landlord (the “Issuing Bank”), in the initial amount of the Additional Security Deposit (Two Hundred Sixty-
Three Thousand Eight Hundred Two and 81/100 Dollars ($263,802.81)), less any Cash Component issued to
Landlord (each subject to adjustment as provided for above), to be held by Landlord as security for the faithful
performance and observance by Tenant of all its obligations under the provisions of the Lease.
(b)
Any such LOC shall be in form and substance as approved in writing by Landlord, in its
reasonable discretion. Any LOC must permit and include the following provision: “Partial Draws and Multiple
Presentations are Allowed.” The following statement shall be included in any LOC for Landlord’s right to draw
against the LOC as the beneficiary thereunder: “The undersigned is a Vice-President or other officer of WPT Land
2 GP LLC, General Partner of WPT Land 2 LP, and is authorized to draw on this Irrevocable Standby Letter of
Credit in the amount of ___________________ Dollars ($_____).” The LOC shall be unconditional, irrevocable,
transferable, and payable to Landlord, in partial or full draws, on
7
sight by presentation of the original demand for payment to Issuing Bank by overnight courier service on a
business day at Issuing Bank’s office, or by facsimile transmission (in which the presentation of the original
demand for payment shall not be required), and simultaneously under telephone advice, all as set forth in the
LOC. Any and all fees or costs charged by the Issuing Bank in connection with the LOC, including any
assignment thereof by Landlord, shall be paid by Tenant.
(c)
The LOC shall expire not earlier than twelve (12) months after the date of delivery thereof
to Landlord and shall provide that the same shall be automatically renewed for successive twelve (12) month
periods, without amendment, unless at least ninety (90) days prior to the then current expiration date of the LOC,
Issuing Bank sends, and Landlord receives, written notice to Landlord and Tenant that the LOC will not be
extended beyond the then current expiration date of the LOC. If the Issuing Bank does not renew the LOC at any
time prior to the Outside LOC Expiration Date, and if Tenant does not deliver a substitute LOC in the in the
amount of the Security Deposit, at least thirty (30) days prior to the expiration of the then current LOC period,
then, such nonrenewal and failure to substitute shall be an Event of Default hereunder, and in addition to its rights
granted under this Section 7, Landlord shall have the right to draw on the existing LOC and to require Tenant to
deliver to Landlord a cash Security Deposit under and subject to Section 7(j) below. Tenant’s failure to comply
with the terms and conditions of this Section 7 shall be deemed an Event of Default hereunder.
(d)
Landlord shall have the right to draw upon the LOC from time to time, in whole or in part,
upon any Event of Default under the Lease, or for the payment of any amount as to which Tenant is in default or
to compensate Landlord for any loss or damage it may suffer by reason of Tenant’s default under the Lease, or for
any other reason permitted by the Lease or arising out of a failure of Tenant to pay or reimburse Landlord for any
obligation of Tenant hereunder beyond the period required therefor (a “Draw Condition”), and apply the
proceeds thereof, whereupon Tenant, within ten (10) business days after any such draw, shall either (1) restore the
LOC to the applicable amount of the Security Deposit, or (2) post a cash security deposit in the applicable amount
of the Security Deposit with Landlord. Tenant’s failure to restore the LOC or deposit the cash equivalent to
Landlord shall be deemed an Event of Default under the Lease. Should Landlord elect to draw the full amount of
the LOC upon a Draw Condition, notwithstanding anything contained herein to the contrary, Tenant expressly
waives any right it might have, and will not take any action whatsoever to prevent Landlord from drawing on the
LOC, whether in whole or in part, and agrees that an action for damages, and not injunctive or other equitable
relief related to the LOC, shall be Tenant’s sole remedy which shall only be brought by Tenant pursuant to a direct
claim against Landlord and not, under any circumstances, with, through or against the Issuing Bank, in the event
Tenant disputes Landlord’s claim to any such amounts. Under no circumstances shall any such claim be brought
by Tenant against Issuing Bank or against Landlord through the Issuing Bank for any reason including, without
limitation, by reason of any dispute by Tenant that Landlord is not entitled to draw on, or against, the LOC.
(e)
The LOC shall be subject to the Uniform Customs and Practice for Documentary Credits,
International Chamber of Commerce Publication No. 600 (2007 Revision).
8
(f)
The Issuing Bank shall have a Moody’s rating of at least “A-3” (or other comparable
rating). If at any time (a) the Issuing Bank is either (i) closed by the Federal Deposit Insurance Corporation
(“FDIC”) or any other governmental authority, or (ii) declared insolvent by the FDIC or other governmental
agency for any reason, or (b) Landlord reasonably believes that Issuing Bank will either be (y) closed by the FDIC
or any governmental authority, or (z) declared insolvent by the FDIC or other governmental authority for any
reason, Tenant shall, within fifteen (15) days after either the occurrence of such closure or declaration of
insolvency or notice from Landlord that Landlord reasonably believes that Issuing Bank will close or be declared
insolvent, either (1) provide Landlord a replacement LOC satisfying all of the terms of this Section 7, or (2) post a
cash security deposit in the amount of the Security Deposit with Landlord, and if Tenant fails to comply with this
Section 7(f), an Event of Default shall be deemed to have occurred hereunder as of the end of such five (5) day
period.
(g)
Landlord shall have the right to pledge or assign its interest in the LOC and the proceeds
thereof to any Mortgagee of the Premises. In the event of a sale or transfer of Landlord’s estate or interest in the
Premises, Landlord shall have the right to transfer, at Landlord’s cost, the LOC, or the proceeds thereof, to the
extent not applied as set forth above, to the vendee or transferee as the new landlord under this Lease, and to the
extent the LOC, or the proceeds thereof (to the extent not applied as set forth above) are so transferred, Landlord
shall be considered released by Tenant from all liability for the return of the LOC, or the proceeds thereof, but
only if the transferee assumes Landlord’s obligations under this Lease. No Mortgagee or purchaser of the
Premises at any foreclosure proceeding brought under the provisions of any Mortgage shall (regardless of whether
the Lease is at the time in question subordinated to the lien of any Mortgage) be liable to Tenant or any other
person for any or all of such sums or the return of any LOC (or any other or additional security deposit or other
payment made by Tenant under the provisions of the Lease), unless Landlord has actually delivered the LOC, or
the proceeds thereof, to such Mortgagee or purchaser. If requested by any such Mortgagee or purchaser, Tenant,
at Tenant’s sole cost and expense, shall obtain an amendment to the LOC which names such Mortgagee or
purchaser as the beneficiary thereof in lieu of Landlord. Notwithstanding the foregoing provisions of this Section
7, while the LOC may be transferable one or more times, in each instance it may only be transferred to a single
transferee and only in the full amount available to be drawn under the LOC at the time of such transfer. Any such
transfer must be effected only through Issuing Bank by presentation to the Issuing Bank at the address specified
on the LOC, along with a duly completed bank transfer form, if required, and the original of the LOC, and any
amendments. Each transfer shall be evidenced by the Landlord’s endorsement on the reverse of the original of the
LOC, and the Issuing Bank shall deliver the original of the LOC so endorsed to the transferee.
(h)
Tenant acknowledges that Landlord will incur costs in connection with the review and
negotiation of all annual LOC renewals as provided for herein. Accordingly, Tenant shall promptly pay to
Landlord the amount of all Landlord’s actual costs (including, without limitation, Landlord’s reasonable attorneys’
fees) incurred by Landlord in connection with each renewal thereof and any draw against the LOC by Landlord;
provided those costs shall not exceed Two Thousand Dollars ($2,000) per review.
(i)
In the event the LOC ceases to comply with all of the requirements of this Section 7, or if
Issuing Bank terminates the LOC and the LOC is not replaced with a substitute
9
LOC acceptable to Landlord, in its sole discretion at least thirty (30) days prior to such termination date, and
complying with all of the requirements of this Section 7, Tenant shall deposit with Landlord cash in the then
current amount of the LOC to be retained by Landlord as cash security for the faithful performance and
observance by Tenant of the provisions of this Lease. Tenant shall not be entitled to any interest on the cash
Security Deposit. Landlord shall have the right to commingle the cash Security Deposit with its other funds.
Landlord may use the whole or any part of the cash Security Deposit for the payment of any amount as to which
Tenant is in default or to compensate Landlord for any loss or damage it may suffer by reason of Tenant’s default
under this Lease. If Landlord uses all or any portion of the cash Security Deposit as herein provided, within ten
(10) days after demand, Tenant shall pay Landlord cash in an amount equal to that portion of the cash Security
Deposit used by Landlord. If Tenant complies fully and faithfully with all of the provisions of this Lease, the cash
Security Deposit shall be returned to Tenant within fifteen (15) days after the Outside LOC Expiration Date.
8.
Brokers. The Parties agree and represent to each other that they have dealt with no brokers in
connection with this Fourth Amendment. Each party agrees to indemnify and hold the other harmless from any
and all claims arising from a breach of the foregoing representation and from any and all claims for commissions
or fees in connection with this Fourth Amendment from any real estate brokers or agents with whom they may
have dealt.
9.
Survival; PA Remedies. All references to the “Lease” shall refer to the Lease as modified by this
Fourth Amendment. Except as expressly modified herein, the terms and conditions of the Lease shall remain
unchanged and in full force and effect in accordance with its terms. Specifically, without limitation, in the case of
an Event of Default by Tenant with respect to any of its obligations under the Lease, Landlord shall be entitled to
pursue all remedies available under the Lease, or otherwise available at law or in equity. Accordingly, Tenant
agrees to the following:
(a)
When the Lease and the Term, or any renewal or extension thereof, shall have been
terminated on account of any Event of Default by Tenant, or when the Term or any renewal or extension thereof
shall have expired, Tenant hereby authorizes any attorney of any court of record of the Commonwealth of
Pennsylvania, to appear for Tenant and for anyone claiming by, through or under Tenant and to confess judgment
against all such parties, and in favor of Landlord, in ejectment and for the recovery of possession of the Premises,
for which the Lease, or a true and correct copy thereof, shall be good and sufficient warrant. AFTER THE
ENTRY OF ANY SUCH JUDGMENT, A WRIT OF POSSESSION MAY BE ISSUED THEREON
WITHOUT FURTHER NOTICE TO TENANT AND WITHOUT A HEARING. If for any reason after such
action shall have been commenced it shall be determined and possession of the Premises remain in or be restored
to Tenant, Landlord shall have the right for the same Event of Default and upon any subsequent Event of Default
or upon the termination of the Lease, or Tenant’s right of possession as therein set forth, to again confess
judgment as therein provided, for which the Lease, or a true and correct copy thereof, shall be good and sufficient
warrant.
(b)
If an Event of Default occurs relating to Tenant’s non-payment of the Rent due under the
Lease, Tenant hereby authorizes any attorney of any court of record of the Commonwealth of Pennsylvania, to
appear for Tenant and to confess judgment against Tenant,
10
and in favor of Landlord, for all Rent due hereunder plus costs and an attorney’s collection commission equal to
the greater of 10% of all Rent or $1,000.00, for which the Lease, or a true and correct copy thereof, shall be good
and sufficient warrant. TENANT UNDERSTANDS THAT THE FOREGOING PERMITS LANDLORD TO
ENTER A JUDGMENT AGAINST TENANT WITHOUT PRIOR NOTICE OR HEARING. ONCE
SUCH A JUDGMENT HAS BEEN ENTERED AGAINST TENANT, ONE OR MORE WRITS OF
EXECUTION OR WRITS OF GARNISHMENT MAY BE ISSUED THEREON WITHOUT FURTHER
NOTICE TO TENANT AND WITHOUT A HEARING, AND, PURSUANT TO SUCH WRITS,
LANDLORD MAY CAUSE THE SHERIFF OF THE COUNTY IN WHICH ANY PROPERTY OF
TENANT IS LOCATED TO SEIZE TENANT’S PROPERTY BY LEVY OR ATTACHMENT. IF THE
JUDGMENT AGAINST TENANT REMAINS UNPAID AFTER SUCH LEVY OR ATTACHMENT,
LANDLORD CAN CAUSE SUCH PROPERTY TO BE SOLD BY THE SHERIFF EXECUTING THE
WRITS, OR, IF SUCH PROPERTY CONSISTS OF A DEBT OWED TO TENANT BY ANOTHER
ENTITY, LANDLORD CAN CAUSE SUCH DEBT TO BE PAID DIRECTLY TO LANDLORD IN AN
AMOUNT UP TO BUT NOT TO EXCEED THE AMOUNT OF THE JUDGMENT OBTAINED BY
LANDLORD AGAINST TENANT, PLUS THE COSTS OF THE EXECUTION. Such authority shall not be
exhausted by one exercise thereof, but judgment may be confessed as aforesaid from time to time as often as any
of the Rent and other sums shall fall due or be in arrears, and such powers may be exercised as well after the
expiration of the initial term of the Lease, and during any Renewal Term of the Lease, and after the expiration of
any Renewal Term of the Lease.
(c)
The warrants to confess judgment set forth above shall continue in full force and effect and
be unaffected by amendments to the Lease, or other agreements between Landlord and Tenant even if any such
amendments or other agreements increase Tenant’s obligations or expand the size of the Premises.
(d)
TENANT EXPRESSLY AND ABSOLUTELY KNOWINGLY AND EXPRESSLY
WAIVES AND RELEASES (i) ANY RIGHT, INCLUDING, WITHOUT LIMITATION, UNDER ANY
APPLICABLE STATUTE, WHICH TENANT MAY HAVE TO RECEIVE A NOTICE TO QUIT PRIOR
TO LANDLORD COMMENCING AN ACTION FOR REPOSSESSION OF THE PREMISES AND (ii)
ANY RIGHT WHICH TENANT MAY HAVE TO NOTICE AND TO HEARING PRIOR TO A LEVY
UPON OR ATTACHMENT OF TENANT’S PROPERTY OR THEREAFTER AND (iii) ANY
PROCEDURAL ERRORS IN CONNECTION WITH THE ENTRY OF ANY SUCH JUDGMENT OR IN
THE ISSUANCE OF ANY ONE OR MORE WRITS OF POSSESSION OR EXECUTION OR
GARNISHMENT THEREON.
10.
Lease Confirmation. Tenant acknowledges and agrees that the Lease is in full force and effect
and Tenant, to its knowledge, has no claims or offsets against Rent due or to become due under the Lease.
Landlord acknowledges and agrees that the Lease is in full force and effect and Landlord, to its knowledge, has
no claims against Tenant under the Lease. Prior to the execution of this Fourth Amendment, Landlord and Tenant
acknowledge that there have been no changes, amendments or modifications of any nature to the Original Lease
other than as set forth in Background Section A above.
11
11.
Integration. The Lease represents the entire agreement between the parties hereto and there are no
collateral, written or oral agreements or understandings between Landlord and Tenant with respect to the Original
Premises, the Expansion Premises or the Building not reflected or incorporated in the Lease. No representations
or promises will be binding on the parties to the Lease, except those representations and promises expressly
contained in the Lease.
12.
Amendments. The Lease shall not be modified in any manner except by an instrument in writing
executed by the parties.
13.
Drafting. Both parties having participated fully and equally in the negotiation and preparation of
this Fourth Amendment, this Fourth Amendment shall not be more strictly construed, nor any ambiguities in the
Lease resolved, against either Landlord or Tenant.
14.
Independent Covenants. Each covenant, agreement, obligation, term, condition or other
provision contained in the Lease, shall be deemed and construed as a separate and independent covenant of the
party bound by, undertaking or making the same, not dependent on any other provision of the Lease, unless
otherwise expressly provided. All of the terms and conditions set forth in this Fourth Amendment shall apply
throughout the Term applicable to both the Original Premises and the Expansion Premises unless otherwise
expressly set forth herein.
15.
Successors and Assigns. The Lease shall be binding upon and inure to the benefit of the parties
hereto and their respective successors and permitted assigns.
16. Ministerial Actions. Each of Landlord and Tenant agrees that it will not raise or assert as a
defense to any obligation under this Fourth Amendment, or make any claim that this Fourth Amendment or the
Lease is invalid or unenforceable, due to any failure of this document or the Lease to comply with ministerial
requirements, including requirements for corporate seals, attestations, witnesses, notarizations or other similar
requirements, and each party hereby waives the right to assert any such defense or make any claim of invalidity or
unenforceability due to any of the foregoing.
17.
Severability. If any provision(s) of this Fourth Amendment shall be declared unenforceable in any
respect, such unenforceability shall not affect any other provision of the Lease and each such provision shall be
deemed to be modified, if possible, in such a manner as to render it enforceable and to preserve to the extent
possible the intent of the parties as set forth herein.
18.
Law. The Lease shall be construed and enforced in accordance with the Laws of the
Commonwealth of Pennsylvania (without the application of any conflict of laws principles).
19.
Captions. The captions in this Fourth Amendment are for convenience only, are not a part of this
Fourth Amendment and do not in any way define, limit, describe or amplify the terms of this Fourth Amendment.
20.
Time of the Essence. Time is of the essence with respect to both parties’ obligations under the
Lease.
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21.
Signatures; Multiple Counterparts. This Fourth Amendment may be executed in counterparts,
each of which, when assembled to include a counterpart signed by each party contemplated to sign this Fourth
Amendment, will constitute a complete and fully executed Fourth Amendment. All such fully executed
counterparts will collectively constitute a single Fourth Amendment. Landlord and Tenant expressly agree that if
the signature of Landlord and/or Tenant on this Fourth Amendment is not an original, but is a digital, mechanical
or electronic reproduction (such as, but not limited to, e-mail or PDF), then such digital, mechanical or electronic
reproduction shall be as enforceable, valid and binding as, and the legal equivalent to, an authentic and traditional
ink-on-paper original wet signature penned manually by its signatory.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, Landlord and Tenant, intending to be legally bound, have executed this
Fourth Amendment as of the day and year first above written.
LANDLORD:
WPT LAND 2 LP
By:WPT LAND 2 GP LLC,
its general partner
/s/ Anthony A. Nichols, Jr.
By:
Name:Anthony A. Nichols, Jr.
Title: Senior Vice President
TENANT:
TELA BIO, INC.
/s/ Antony Koblish
By:
Name:Antony Koblish
Title: President & CEO
Signature Page to Fourth Amendment to Lease Agreement
Exhibit A
Premises Plan
Appendix A to Fourth Amendment to Lease Agreement
LIST OF SUBSIDIARIES
Exhibit 21.1
Subsidiary
TELA Bio, Limited
Ownership Percentage
100%
Jurisdic on of Incorpora on or
Organiza on
England and Wales
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the registration statements (No. 333-275511) on Form S-3 and (Nos. 333-270803, 333-
263797, 333-245707 and 333-235241) on Form S-8 of our report dated March 22, 2024, with respect to the consolidated financial
statements of TELA Bio, Inc.
Exhibit 23.1
/s/ KPMG LLP
Philadelphia, Pennsylvania
March 22, 2024
CERTIFICATION
Pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934,
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
EXHIBIT 31.1
I, Antony Koblish, certify that:
1. I have reviewed this Form 10-K of TELA Bio, 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 the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial 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 in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is
being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the
registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting;
and
5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the 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 are reasonably likely to adversely affect the registrant's ability to record, process, summarize and
report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant's internal control over financial reporting.
Date: March 22, 2024
/s/ Antony Koblish
Antony Koblish
President and Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION
Pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934,
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
EXHIBIT 31.2
I, Roberto Cuca, certify that:
1. I have reviewed this Form 10-K of TELA Bio, 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 the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial 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 in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is
being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the
registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting;
and
5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the 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 are reasonably likely to adversely affect the registrant's ability to record, process, summarize and
report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant's internal control over financial reporting.
Date: March 22, 2024
/s/ Roberto Cuca
Roberto Cuca
Chief Operating Officer and Chief Financial Officer
(Principal Financial Officer)
CERTIFICATION
Pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
EXHIBIT 32.1
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and
Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), that: Antony Koblish, Chief Executive Officer of
TELA Bio, Inc. (the “Company”), hereby certifies that, to the best of his knowledge:
(1) The Company’s Annual Report on Form 10-K for the period ended December 31, 2023, to which this Certification is attached
as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange
Act; and
(2) The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
Date: March 22, 2024
/s/ Antony Koblish
Antony Koblish
President and Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION
Pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
EXHIBIT 32.2
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and
Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), that: Roberto Cuca, Chief Operating Officer and
Chief Financial Officer of TELA Bio, Inc. (the “Company”), hereby certifies that, to the best of his knowledge:
(1) The Company’s Annual Report on Form 10-K for the period ended December 31, 2023, to which this Certification is attached as
Exhibit 32.2 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange
Act; and
(2) The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
Date: March 22, 2024
/s/ Roberto Cuca
Roberto Cuca
Chief Operating Officer and Chief Financial Officer
(Principal Financial Officer)
TELA BIO, INC.
COMPENSATION RECOVERY POLICY
Adopted as of November 8, 2023
Exhibit 97.1
TELA Bio, Inc., a Delaware corporation (the “Company”), has adopted a Compensation Recovery Policy (this
“Policy”) as described below.
1.
Overview
The Policy sets forth the circumstances and procedures under which the Company shall recover Erroneously
Awarded Compensation from Covered Persons (as defined below) in accordance with rules issued by the United
States Securities and Exchange Commission (the “SEC”) under the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), and the Nasdaq Stock Market. Capitalized terms used and not otherwise defined herein
shall have the meanings given in Section 3 below.
2.
Compensation Recovery Requirement
In the event the Company is required to prepare a Financial Restatement, the Company shall recover reasonably
promptly all Erroneously Awarded Compensation with respect to such Financial Restatement.
3.
Definitions
a. “Applicable Recovery Period” means the three completed fiscal years immediately preceding the
Restatement Date for a Financial Restatement. In addition, in the event the Company has changed its
fiscal year: (i) any transition period of less than nine months occurring within or immediately
following such three completed fiscal years shall also be part of such Applicable Recovery Period and
(ii) any transition period of nine to 12 months will be deemed to be a completed fiscal year.
b. “Applicable Rules” means any rules or regulations adopted by the Exchange pursuant to Rule 10D-1
under the Exchange Act and any applicable rules or regulations adopted by the SEC pursuant to
Section 10D of the Exchange Act.
c. “Board” means the Board of Directors of the Company.
d. “Committee” means the Compensation Committee of the Board or, in the absence of such committee, a
majority of independent directors serving on the Board.
e. “Covered Person” means any Executive Officer. A person’s status as a Covered Person with respect to
Erroneously Awarded Compensation shall be determined as of the time of receipt of such Erroneously
Awarded Compensation regardless of the person’s current role or status with the Company (e.g., if a
person began service as an Executive Officer after the beginning of an Applicable Recovery Period,
that person would not be considered a Covered Person with respect to Erroneously Awarded
Compensation received before the person began service as an Executive Officer, but would be
considered a Covered Person with respect to Erroneously Awarded Compensation received after the
person began service as an Executive Officer where such person served as an Executive Officer at any
time during the performance period for such Erroneously Awarded Compensation).
f.
“Effective Date” means October 2, 2023.
g. “Erroneously Awarded Compensation” means the amount of any Incentive-Based Compensation
received by a Covered Person on or after the Effective Date and during the Applicable Recovery
Period that exceeds the amount that otherwise would have been received by the Covered Person had
such compensation been determined based on the restated amounts in a Financial Restatement,
computed without regard to any taxes paid. Calculation of Erroneously Awarded Compensation with
respect to Incentive-Based Compensation based on stock price or total shareholder return, where the
amount of Erroneously Awarded Compensation is not subject to mathematical recalculation directly
from the information in a Financial Restatement, shall be based on a reasonable estimate of the effect
of the Financial Restatement on the stock price or total shareholder return upon which the Incentive-
Based Compensation was received, and the Company shall maintain documentation of the
determination of such reasonable estimate and provide such documentation to the Exchange in
accordance with the Applicable Rules. Incentive-Based Compensation is deemed received, earned or
vested when the Financial Reporting Measure is attained, not when the actual payment, grant or
vesting occurs.
h. “Exchange” means the Nasdaq Stock Market LLC.
i. An “Executive Officer” means any person who served the Company in any of the following roles at
any time during the performance period applicable to Incentive-Based Compensation and received
Incentive-Based Compensation after beginning service in any such role (regardless of whether such
Incentive-Based Compensation was received during or after such person’s service in such role): the
president, principal financial officer, principal accounting officer (or if there is no such accounting
officer the controller), any vice president in charge of a principal business unit, division or function
(such as sales, administration or finance), any other officer who performs a policy making function or
any other person who performs similar policy making functions for the Company. Executive officers of
parents or subsidiaries of the Company may be deemed executive officers of the Company if they
perform such policy making functions for the Company.
j.
“Financial Reporting Measures” mean measures that are determined and presented in accordance with
the accounting principles used in preparing the Company’s financial statements, any measures that are
derived wholly or in part from such measures (including, for example, a non-GAAP financial
measure), and stock price and total shareholder return.
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k. “Incentive-Based Compensation” means any compensation provided, directly or indirectly, by the
Company or any of its subsidiaries that is granted, earned or vested based, in whole or in part, upon the
attainment of a Financial Reporting Measure.
l. A “Financial Restatement” means a restatement of previously issued financial statements of the
Company due to the material noncompliance of the Company with any financial reporting requirement
under the securities laws, including any required restatement to correct an error in previously-issued
financial statements that is material to the previously-issued financial statements or that would result in
a material misstatement if the error were corrected in the current period or left uncorrected in the
current period.
m. “Restatement Date” means, with respect to a Financial Restatement, the earlier to occur of: (i) the date
the Board concludes, or reasonably should have concluded, that the Company is required to prepare the
Financial Restatement or (ii) the date a court, regulator or other legally authorized body directs the
Company to prepare the Financial Restatement.
4.
Exception to Compensation Recovery Requirement
The Company may elect not to recover Erroneously Awarded Compensation pursuant to this Policy if the
Committee determines that recovery would be impracticable, and one or more of the following conditions,
together with any further requirements set forth in the Applicable Rules, are met: (i) the direct expense paid to a
third party, including outside legal counsel, to assist in enforcing this Policy would exceed the amount to be
recovered, and the Company has made a reasonable attempt to recover such Erroneously Awarded Compensation;
or (ii) recovery would likely cause an otherwise tax-qualified retirement plan to fail to be so qualified under
applicable regulations.
5.
Tax Considerations
To the extent that, pursuant to this Policy, the Company is entitled to recover any Erroneously Awarded
Compensation that is received by a Covered Person, the gross amount received (i.e., the amount the Covered
Person received, or was entitled to receive, before any deductions for tax withholding or other payments) shall be
returned by the Covered Person.
6.
Method of Compensation Recovery
The Committee shall determine, in its sole discretion, the method for recovering Erroneously Awarded
Compensation hereunder, which may include, without limitation, any one or more of the following:
a.
requiring reimbursement of cash Incentive-Based Compensation previously paid;
b. seeking recovery of any gain realized on the vesting, exercise, settlement, sale, transfer or other
disposition of any equity-based awards;
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c. cancelling or rescinding some or all outstanding vested or unvested equity-based awards;
d. adjusting or withholding from unpaid compensation or other set-off;
e. cancelling or offsetting against planned future grants of equity-based awards; and/or
f.
any other method permitted by applicable law or contract.
Notwithstanding the foregoing, a Covered Person will be deemed to have satisfied such person’s obligation to
return Erroneously Awarded Compensation to the Company if such Erroneously Awarded Compensation is
returned in the exact same form in which it was received; provided that equity withheld to satisfy tax obligations
will be deemed to have been received in cash in an amount equal to the tax withholding payment made.
7.
Policy Interpretation
This Policy shall be interpreted in a manner that is consistent with the Applicable Rules and any other applicable
law. The Committee shall take into consideration any applicable interpretations and guidance of the SEC in
interpreting this Policy, including, for example, in determining whether a financial restatement qualifies as a
Financial Restatement hereunder. To the extent the Applicable Rules require recovery of Incentive-Based
Compensation in additional circumstances besides those specified above, nothing in this Policy shall be deemed to
limit or restrict the right or obligation of the Company to recover Incentive-Based Compensation to the fullest
extent required by the Applicable Rules.
8.
Policy Administration
This Policy shall be administered by the Committee; provided, however, that the Board shall have exclusive
authority to authorize the Company to prepare a Financial Restatement. In doing so, the Board may rely on a
recommendation of the Audit Committee of the Board. The Committee shall have such powers and authorities
related to the administration of this Policy as are consistent with the governing documents of the Company and
applicable law. The Committee shall have full power and authority to take, or direct the taking of, all actions and
to make all determinations required or provided for under this Policy and shall have full power and authority to
take, or direct the taking of, all such other actions and make all such other determinations not inconsistent with the
specific terms and provisions of this Policy that the Committee deems to be necessary or appropriate to the
administration of this Policy. The interpretation and construction by the Committee of any provision of this
Policy and all determinations made by the Committee under this policy shall be final, binding and conclusive.
9.
Compensation Recovery Repayments not Subject to Indemnification
Notwithstanding anything to the contrary set forth in any agreement with, or the organizational documents of, the
Company or any of its subsidiaries, Covered Persons are not entitled to
4
indemnification for Erroneously Awarded Compensation or for any losses arising out of or in any way related to
Erroneously Awarded Compensation recovered under this Policy.
5