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2023 ReportANNUAL REPORT > S L E E P D I A G N O S T I C S & T R E AT M E N T > N E U R O D I A G N O S T I C S > B R A I N R E S E A R C H > U LT R A S O N I C B LO O D F LO W M O N I TO R I N G > M E D I C A L I N N O VAT I O N S O V E R T H I R T Y 02 Who is Compumedics? 03 Financial Summary 04 Chairman’s Address 13 Global Markets 14 Core Business 16 Clients and Core Products 17 Strategic Growth Platforms 21 A Focused Strategy in Action 23 Board of Directors 24 Senior Management Compumedics Limited ABN 95 006 854 897 Annual General Meeting Thursday, 19th November, 2020 at 10.30am To be held at: Compumedics Limited 30-40 Flockhart Street Abbotsford Victoria 3067 and Virtually Who is Compumedics? 1 2 Since 1987 Compumedics has grown into a company: with 130 employees across seven locations, Melbourne, Australia (Home Office), Charlotte, NC, USA, Hamburg, Dresden and Singen, Germany, Paris, France and Daejeon, South Korea. which listed on the ASX on Dec 21, 2000. that has generated more than $660m in revenues since listing of which over $550m have been export revenues All $ = A$ unless otherwise specified FINANCIAL SUMMARY ALL FIGURES IN A$M UNLESS OTHERWISE STATED TREND 2020 2019 Revenue for continuing operations 35.1 41.5 Earnings before interest, income tax, depreciation and amortisation (EBITDA) (underlying) Earnings before interest and income tax (EBIT) (underlying) Net operating profit after tax (NPAT) (underlying) Research and development costs as a percentage of operating revenue Total assets Shareholders funds Net tangible assets per share (cents) Weighted average number of shares (million) Earnings per share (basic) (cents) Earnings per share based on earnings before interest, tax, depreciation and amortisation (cents) 2.3 0.5 1.8 11 5.9 5.4 4.0 13 35.5 38.7 21.8 27.3 10.3 11.6 177 177 0.1 0.1 2.3 2.3 • The FY20 net profit after tax (NPAT) (underlying) was down to AUD1.8M compared to AUD4.0M for the FY19. Earnings before interest, tax, depreciation and amortisation (EBITDA) (underlying) was AUD2.3M compared to AUD5.9M for the FY19. • Revenues shipped and invoiced decreased by 15.5% to AUD35.1M over the previous financial year. Sales orders taken were down by 13.5% to AUD35.2M, for the core business compared to the previous financial year. The decrease in revenues primarily reflects the impact of containment measures around the world in relation to the COVID-19 Pandemic in the second half of FY20. Dr. David Burton, Ph.D. Executive Chairman and Chief Executive Officer Compumedics Limited Dear Compumedics investors, colleagues and business partners, On behalf of the Board, management and the Compumedics team, I present to you the following highlights in the results contained within the Compumedics 2020 Annual Report. Firstly, on behalf of the Board, management and the Compumedics team I would like to extend our thoughts of care and sympathy to all those who have suffered or been adversely impacted during this all- encompassing COVID-19 pandemic. Secondly, whilst our overall performance has obviously been impacted by the lockdown and other adverse events impacting us all, we are also highly conscious and grateful for the continued positive support of those individuals and organisations who have rallied behind Compumedics’ continued and relentless drive forward. Moreover, in the year past, in preparation for a rebound in the years ahead, we have continued to intensify our focus on not only prevailing through these current challenges, but also consolidating our position to build an even stronger growth-oriented business. Compumedics will, as demonstrated during all past global challenges, navigate through this pandemic and emerge a stronger, more resilient and valuable company from both an economic and job creation perspective, but also in accordance to our originating time-held values for people, ethics and contribution. Thirdly, and finally before we review the year in progress and the journey ahead, I would like to take this opportunity to acknowledge and thank the ongoing support of our clients, Compumedics people, the many unsung heroes such as families, partners, colleagues and friends, our Governments, business partners, suppliers, and of course our shareholders and other stakeholders, enabling us to prevail through this extremely challenging COVID-19 pandemic. The COVID 19 pandemic has led to the company temporarily retracting its prior financial performance guidance. Revenue declined 15% to $35.1m for the year ended 30 June 2020, whilst net profit after tax (NPAT) on an underlying basis was down 55% to $1.8m compared to $4.0m for FY19. Earnings before interest, tax, depreciation and amortisation (EBITDA) on an underlying basis were down 61% to $2.3m compared to $5.9m for FY19. The focus on performance continues, even whilst maintaining a strong investment on key breakout growth opportunities including Orion LifeSpan™ MEG system and Somfit® sleep-health platform. Additionally, a strong ongoing focus on quality and efficiency improvements across all operational areas of the business continues to be a priority as we move through the impacts of the COVID-19 pandemic. Revenues shipped and invoiced decreased 15.5% to $35.1m for FY20, compared to $41.5m for FY19. Sales orders taken for FY20 were down 13.5% for the core business compared to FY19. Cash on hand increased to $6.4m for FY20, compared to $4.6m for FY19. Debt levels also increased to $3.5m compared to $1.6m for FY19, this was due to the payroll protection scheme in the US where the company received $0.9m (USD0.6m) which will be forgiven if certain conditions are met by 31 December 2020. In addition, substantial ongoing investments in the form of research and development (R&D) continued in the core neuro and sleep diagnostics business, together with strong commercial activation advancement across both new Orion LifeSpan™ MEG and Somfit® sleep-health business divisions. 3 4 KEY PERFORMANCE MEASURES (FY20 Pandemic Impacts and Opportunities) TM NEXUS 360 CLOUD CLINIC SERVICES STRATEGY TM SOMFIT CONSUMER SLEEP DEVICE COMMERCIALISATION ACTIVITIES ADVANCE FIRST MEG INSTALLATION PROGRESSING 46 SITES NEXUS 360 TM 53% ORDERS TAKEN (CORE BUSINESS) $35.2M Down 13.5% 270 BEDS NEXUS 360 TM 29% NET PROFIT AFTER TAX (UNDERLYING)55% 75,000 STUDIES NEXUS 360 TM 67% EBITDA LY (UNDER ING) 61% $1.8M in FY20 vs $4.0M in FY19 $2.3M in FY20 vs $5.9M in FY19 REVENUE $35.1M DOWN FROM $41.5M IN FY19 CORE BUSINESS* EBITDA $3.6M $3.6M in FY20 vs $7.4M in FY19 CORE BUSINESS* NET PROFIT AFTER TAX $3.7M $3.7M in FY20 vs $5.9M in FY19 *Excludes Medical Innovation Strategic Investments Further underscoring the strength of the core business profitability, over $3.0m was invested in next-generation growth platforms (medical innovations) including the new magnetoencephalography (MEG) neuroimaging business, eHealth (professional) sleep cloud services (Nexus 360), and Somfit® sleep-health platform, positioning Compumedics for ongoing growth coupled with significant upcoming business realisation opportunities. A number of key milestones and positive outcomes were achieved during the 30 June 2020 (FY20) financial year. In particular, the US FDA 510(K) market clearance in February 2020 of our Neuroscan Orion LifeSpan™ MEG system paves the way for further commercial activation of this product. Gross margins declined from 57% in FY19 to 51% in FY20, largely due to the decline in sales volumes, but still positively offset by our strengthened operational management team and reinvigorated drive to continue efficiency improvements throughout the organisation. OPERATIONS Solid Underlying Financial and Operational Performance. Compumedics continues to focus on its core strategy and operational execution, by way of early adaptation and deployment of a range of new operational productivity and business growth initiatives, designed to ultimately overcome the temporary pandemic setbacks. Moreover, the company has continued to maintain its underlying profitability and prudent cash management, as an essential element to its sustainability and related global job security, stability and certainty moving forward. As already noted, we are highly grateful to our Compumedics people, partners, suppliers, shareholders and other stakeholders, especially those who have taken the extra time to understand how we are not only navigating through the current challenges but clearly focussed on emerging as a stronger company with reinforced and expanded growth prospects, to further bolster future performance outcomes from our well established blue-chip customer based core business. Ongoing Performance and Profitability Improvements. Importantly, both immediate refreshing of all sleep and neurodiagnostic product pipelines has been clearly demonstrated with new cutting-edge remote monitoring platforms now under regulatory market release processes. With the heightened use of online remote, telemedicine systems, Compumedics new range of Okti™ remote neurology and Falcon HST systems is ideally timed. Compumedics remains focussed on continued review and potential improvement programs and initiatives, throughout the organisation. New operational key performance indicators continue to be deployed as a means of pre-empting potential or emergent issues, in order to enhance quality, whilst continuing to strive for reducing waste, and enhancing productivity and efficiencies. Naturally, these aspects are designed to translate into greater corporate sustainability, including enhanced sales margins and profitability. As per prior years, these programs cover areas such as improving purchasing effectiveness and efficiencies, strengthening manufacturing, reinforcing our internal Compumedics manufactured consumable business strength and growth, and streamlining of logistics. Other programs continue to focus on continued growth and strengthening of our broad range of recurring revenue opportunities, enhanced online shopping cart capabilities, and implementation of global 24-hour help-desk support services. PRODUCT DEVELOPMENT PIPELINE The 2020 year in progress was a year of substantial research and development advancements along with regulatory activities, positioning Compumedics for a range of blockbuster new product releases and roll-outs for the 2021 year ahead. In particular, the new products rollouts play into Compumedics’ greatest ongoing legacy and strengths and the markets greatest current demands. That being the need for telemedicine or remote monitoring systems. In terms of Compumedics ongoing legacy, the company’s first generation of ambulatory systems (Compumedics P-Series) won some of the world’s most technologically competitive diagnostic monitoring contracts, including 2 NASA astronaut monitoring contracts (Space Shuttle and Space Station Missions). Compumedics was also awarded the contract to equip the world’s first and largest home sleep study of its kind (USA NIH funded 14000 patient Sleep Heart Health Study SHHS). Novel findings of the SHHS included increased incidence of heart failure amongst severe OSA sufferers (Gottlieb DJ et al. 2010) and the SDB association with all- cause mortality, and specifically coronary artery disease (Quan SF et al. 2009). Compumedics won the highly competitive and prestigious NIH tender against 21 world leading sleep companies and the study involved 18 USA Medical Institutions/Organisations. Consequently, to now be in the regulatory process phase in preparation for the imminent release of both Compumedics’ newly developed neuro and sleep diagnostic remote/telemedicine systems, comprising of the Okti ™ and “Falcon” HST ranges, respectively, is extraordinary positioning for core and emergent market business growth, for the year ahead, and beyond. In general, Product R&D, across both core product groups, in conjunction with breakout business divisions, was maintained across all the Company’s divisions with a range of product updates, new product releases, and refreshed product pipelines. This underpins rapid emergence from the current pandemic set-back towards strong ongoing growth across the Compumedics® sleep, neuro-diagnostic, Neuroscan® research, DWL® (ultrasonic Doppler blood flow) and consumable businesses. Compumedics ® “Falcon”™ HST Solution Compumedics® CORiSS™ Cortical Stimulator “Falcon” HST As noted above Compumedics led the market in diagnostic remote/ telemedicine monitoring and the new “Falcon” home sleep testing (HST) product range ushers in a new era of affordable premium HST performance capabilities. These capabilities include streamlined user- friendly interface, fully integrated with the Nexus 360 platform. The product represents a leap forward in HST usability with a focus on the ability for the patient to attach the device without reliance on technician intervention. Coupled with advanced communications technology and a raft of convenience features the new HST range will change the way our customers approach the HST market. Okti ™ Compumedics has led the way in high density clinical systems for advanced epilepsy recordings as well as ambulatory portable acquisition. The Neuvo and Siesta products are still best in class in their segments. After several years in development, the latest generation of Compumedics amplifiers targeting the electroencephalograph market is only months away from release. This amplifier combines the best of the Neuvo and Siesta product lines in a single product. The Okti range will provide the markets leading solution for both ambulatory, long term, high density and research applications. With a focus on usability and size, including features specifically aimed at the increasing focus on cyber security in medicine, Okti represents a leap forward in both standard clinical practice and advanced data collection. With a fully integrated usability solution with a focus on disposable accessories, the Okti is optimised for the current and future needs of the clinical and research user. Compumedics ® Okti™ Clinical and Research EEG System CORiSS ™ Cortical stimulation is an increasing requirement for high-end epilepsy surgery programs. The need for a fully integrated cortical stimulator and switch matrix to allow neurologists and neurosurgeons to map out functional areas of the brain is becoming increasingly important as surgery emerges as the leading treatment for epilepsy. The Coriss cortical stimulator from Compumedics is designed to address this need and seamlessly integrate into the family of Compumedics products to provide a complete end-to-end solution. The Coriss product is finished awaiting final regulatory data collection. While this has been impacted by COVID-19 we expect its market release within 6 months. Profusion ™ EEG Profusion™ EEG is the clinical neurology software solution from Compumedics. It compliments the Profusion™ PSG, CURRY® and Nexus™ 360 products in providing a complete solution for Neurology clinical activities. With the release of version 5 of the EEG software last year we will be following it up this year with a number of breakout enhancements focused on the usability with an increasing focus on advanced algorithms to enhance the automated tools at the clinicians disposal. 5 6 Compumedics ® Profusion EEG™ Profusion NeXus ™ 360 Compumedics ® Profusion NeXus™ 360 Nexus™ 360 continues to deliver the only full HTML 5 based laboratory management solution on the market. Now established as a leading solution with an expanding installed base it continues to grow in capabilities and features. The addition of full native application support as well as full cloud-based solutions and now with full support for neurology laboratories, Nexus™ 360 continues to be the leading cloud or on-premise solution for efficient, standards compliant, secure management of patient data. Having established a strong foundation in the USA sleep diagnostics markets, significant in-roads have also been made into neuro- diagnostics and ambulatory EEG monitoring. Both the Compumedics/ cloud-hosted and on-premises deployment models have continued to expand in functionality and reliability with greater platform adoption in the Australian sleep and neuro-diagnostic markets whilst also serving as a platform for the Somfit home-monitoring device. Leveraging from this success, international adoption of Nexus™ 360 has been achieved with installations in France, Thailand and New Zealand, alongside increased pipeline activity in Europe, South America and the Middle East. Additional product variants are currently under consideration for improved performance and greater uptake in small (1-4 bed facilities) that require a simplified database and remote accessibility. DWL® CONTINUED MARKET GEOGRAPHICAL DIVERSITY AND MARKET EXPANSION DRIVES PERFORMANCE Despite an extraordinary year of COVID-19 consequences, including a 30% decrease in DWL China business, DWL’s global expansion initiatives still paved the way for an overall growth of 4% in the 2020FY. Some of these special performance highlights included United Kingdom sales growth of 155%, with Japan increasing by 66%, Vietnam up 66% from the prior year and DWL USA, Inc. was up 16% setting new records with over 1 million dollars in sales. These results position DWL well for the year ahead, with some extraordinary breakout product developments, such as robotic TCD to potentially transform diagnostic areas such as traumatic brain injury (TBI) and stroke diagnosis and management. The China market now also appear to be returning to strong growth following a temporary COVID-19 pause. In fact, quarter 1 of this year including China demonstrates record business and COVID-19 rebound. DWL Continued Innovation and Diversity in TCD application DWL is focused on expanding markets in intensive care medicine, stroke management, cardio surgery, anesthesia, neuro monitoring and neurosurgery. TCD in use with COVID-19 Research results say that COVID-19 can be particularly dangerous in patients whose vascular function is already impaired and then leads to vascular inflammation, heart attack, stroke. TCD can help for early detection and therapy determination. DWL in use for Traumatic Brain Injuries (TBI) The development of robotic ultrasound will further strengthen the role of DWL in TBI diagnosis in the field of emergency and ICU for sports, battle fields and ambulances. The upcoming DWL TBI detection solution will consist a dedicated automatic software solution and a robotic vessel detector. DWL® Robotic Vessel Detector DWL® TCD in use with COVID-19 TCD in use with Sickle Cell (SC) Anemia Sickle cell anemia is the result of sickle-shaped blood cell deformations, which often leads to stroke. DWL TCD is offering the unique opportunity to measure the vessel sections with the highest blood flow speeds and developed a special SC report for faster diagnosis. DWL is supplier for a medicine approval confirmatory study for treatment of SCD patients involving up to 50 intercontinental study sites and is well on the way to becoming the golden standard for SC diagnostics. TCD in use for stroke management DWL TCD has its unique performance in detecting cerebral micro emboli. With this therapy can be determined more precisely and stroke patients can be protected against possible consequential damage with appropriate measures. In cooperation with European reference centers DWL is improving its emboli detection algorithm and equip a global multi-center study with DWL TCD systems. TCD in use for Neurosurgery Intraoperative examinations directly on the blood vessels enables neurosurgeons to control the quality of intra-operative surgery. With the new EZ-Dop™ system the potential to expand this market is huge. DWL® EZY-Dop™ System TCD with Neuromonitoring Analysis (NMA®) The use of the innovative screening software Neuromonitoring Analysis (NMA®) allows cardiovascular surgeons, anaesthetists and intensivists quickly and reliably interpret the TCD signal in complex clinical situations providing valuable information for further disease assessment and therapy control. DWL for patient data management DWL offers a digital output interface to Philips IntelliVue® Monitors for clinical monitoring as well as an output interface to Cambridge ICM+® for brain monitoring. Dr. David Burton, Compumedics CEO with Mr. Thomas C. Bour, BNI COO. Compumedics® Neuroscan Orion LifeSpan™ MEG system ORION LIFESPAN™ MEG INSTALLED AT BNI the First-phase delivery of initial Compumedics/Neuroscan Orion LifeSpan™ MEG system to USA-based Barrow Neurological Institute (BNI) at St. Joseph’s Hospital and Medical Center, located in Phoenix, Arizona, was completed at the start of the second quarter of 2019. This first phase focused on delivery of a system specifically designed for the evaluation of adult patients with unprecedented accuracy. The second , scheduled for FY20, was, like many other international projects, interrupted by COVID-19 restrictions on travel. Not sitting idle, we have taken the opportunity to further improve the design for the second and final stage of installation which includes the paediatric helmet, now planned for late 2020. This final stage of installation will of course be contingent upon the lifting of international travel restrictions. While the initial post-installation recordings demonstrated the high quality of the magnetic field measures of brain activity, a number of changes have been implemented to further improve the signal-to-noise performance of the system. These include hardware changes to “harden” the systems resistance to radiated noise as well as software implementation of the latest algorithms for separating and suppression environmental noise from the brain’s magnetic field activity. Combined, these changes have significantly reduced noise levels in the traditional frequency used for neuro clinical diagnostics. The engineers at Compumedics Neuroscan, in partnership with our engineering partners at the Korea Research Institute for Science and Standards, continue to push for a much wider frequency range of performance, which will allow clinicians to perform their critical investigation into new frontiers. Fully powered by the CURRY® acquisition and analysis software, Compumedics/Neuroscan Orion LifeSpan™ MEG system will continue to expand the functionality for clinical/research MEG brain signal acquisition and analysis. ORION LIFESPAN™ MEG CERTIFIED FOR CLINICAL USE IN THE USA The Compumedics/Neuroscan Orion LifeSpan™ MEG system was submitted to the Department of Health and Human Services of the United States Food and Drug Administration for certification to allow clinical use of the instrument. After a thorough examination process which included attestations of safety, effectiveness, signal-to-noise ratio compared to earlier MEG technology and localization accuracy, the device was granted a 510(k) number allowing it to be marketed and used clinically. The granted indications for use state that “the Orion LifeSpan MEG non- invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning. ” Furthermore, the system installed at the company’s beta site was field- evaluated by Underwriters Laboratories (UL) and given registration marks. The Magnetically Shielded Room there was likewise evaluated and successfully marked. The Orion LifeSpan™ uses the advanced CURRY® software platform for both acquisition and analysis of MEG/EEG data. This software was previously fully FDA certified with a 510(k) number. Via CURRY®, the Compumedics/ Neuroscan Orion LifeSpan™ MEG system exclusively inherits the “gold standard” functionality for clinical/research MEG brain signal acquisition and analysis. Likewise, the SynAmps EEG used with the system was also previously fully FDA certified with a 510(k) number. These certifications will allow users of the company’s technology to evaluate clinical epilepsy patients and those about to undergo resective brain surgery. Furthermore, they open the door for Compumedics to the larger mainstream clinical market within the USA. Other regulatory submissions, for example to Health Canada and the European CE Mark are now underway. 7 8 ONGOING ACTIVITIES TO DRIVE GROWTH A submission to the FDA in June of 2019, culminated in a successful completion of the FDA 510(K) in February 2020. Following the completion of this critical 510(k) clearance, other regulatory submissions to Health Canada and the European CE Mark are now underway. On the R&D front, further development continues on more comprehensive MEG offerings for both clinical and research applications with new MEG designs. These will accommodate both sitting and lying (supine) positions. These advancements, added to the existing two-helmet, supine-only design, will allow the company to address unmet needs in the adult/paediatric cognitive neurosciences market. This is in addition to features which allow the simultaneous testing of two patients or subjects simultaneously, which is of great interest in the emerging field of cognitive social science. The ongoing improvements currently being integrated into the Orion design, coupled with FDA regulatory clearance for clinical use and the exclusive patented feature of the Compumedics/Neuroscan Orion LifeSpan™ MEG system will allow Compumedics Neuroscan to vigorously compete for all new MEG tenders as well as upgrades worldwide. Enhancements to the Orion LifeSpan™ system include improvements to the CURRY acquisition/analysis software, environmental noise cancellation algorithms, along with more comprehensive MEG offerings for both clinical and research applications with new designs and ergonomics. These advancements, added to the existing offerings, will allow the company to address unmet needs in the adult/paediatric cognitive neurosciences market. These advancements will allow us to vigorously compete for all new MEG business worldwide. With the delays imposed by COVID-19 restrictions, Compumedics is taking the opportunity, along with our beta site colleagues at BNI to further test all aspects of the Orion MEG/EEG system so that any outstanding issues and opportunities to further enhance performance of the system can be incorporated into the final Phase II installation. Compumedics plans to continue putting in place close working relationships between the company and the large CURRY® installed base, along with those facilities who will be using the Orion Lifespan™ MEG. This includes validation studies supporting new applications for MEG; cognitive function and dysfunction research; protocol development, especially those that will directly lead to clinical biomarkers; validation and verification studies; improved/ expanded funding for MEG, including research grants and especially clinical reimbursements (both public and private); etc. The company has a strong interest in expanding the role of MEG in detecting and diagnosing epilepsy, autism, dementia, Parkinson’s disease and other brain/nervous system disorders. Neuroscan CURRY ® and STIM™ In the next few months, version 9 of CURRY® will be replaced, once regulatory documents have been completed. This newest version of the Compumedics Neuroscan software platform, long recognized as the industry standard, has a number of new features and modules. These include a direct communication with PACs servers, the standard platform for storage of neuroimaging data including, MRI, fMRI, PET, CT, SPECT, and DTI data, all of which CURRY® can integrate and co- register. There is also a brand-new spike and seizure module, based on machine learning algorithms. Based on prior knowledge and training from data sets marked by epilepsy experts, this module provides precise capture of inter-ictal epilepsy spikes, with ability to sort spikes into different groups, and then perform source localization using a number of dipole or current-density reconstruction options. Seizure detection also allows the automatic marking of seizure onset and the identification of the EEG channels associated with this onset. Currently, Compumedics Neuroscan is working to transfer the functionality of this module from CURRY®, across to the Profusion™ EEG software, so it is also available CURRY® Neuroimaging Software across the entire platform of Compumedics Clinical EEG products. This module allows Compumedics to compete directly with other vendors in the market who already provide such functionality. In addition to these new features, CURRY® now includes full processing of Diffusion Tensor Imaging or DTI data, with a full white matter tractography module. Tractography, extracted from diffusion tensor imaging MRI data, provides a detailed view of the “wiring” of the brain. While the grey matter of the brain is the origin of all cognitive function, the white matter axonal fibre tracts provide the backbone of communication between different areas of the brain. C CURRY® D DTI Fiber-Tracking data Parallel with the significant changes in version 9 of CURRY®, work is progressing on developing a fully integrated high-density clinical EEG system with full capability of measuring brain activity evoked by the presentation of auditory, visual, tactile, or other forms of sensory stimulus presentation. Clinically, and for both EEG and MEG, this can be used to identify eloquent cortex, both from scalp EEG recordings and grid, depth, and stereotactic EEG recordings. Combined with a large expansion of functionality in CURRY® version 9 for pre-surgical planning, this platform offers a new fully integrated functionality for neurology programs that include neurosurgical treatment for epilepsy. STIM™2, the experimental design software package has always focused on a core set of functions with a simple, easy to use programming interface. In the upcoming year, Compumedics Neuroscan will release an update to STIM™2 with an even simpler-to-use interface that allows the user to execute a number of standard auditory, visual, and tactile stimulation tasks with just a single click. There is no need to enter the programming interface with this new update. And to further expand functionality, this new interface allows customization for user-designed paradigms. As part of the purchase of STIM™2 with a support contract, users will be able to solicit programming assistance from the Neuroscan engineering team to develop custom paradigms that can be added to the one-click user interface. Compumedics/Neuroscan Fast-Emerging Orion LifeSpan™ MEG Brain Scanner Division Magnetoencephalography (MEG) is the most sensitive and precise functional brain imaging technique currently available. It measures and localises signals using helmet-shaped arrays of superconducting sensors in real-time at a millisecond rate with millimetre accuracy. It is completely non-invasive, safe and silent. It has applications in both neuroscience and clinical diagnostics. Currently fewer than 200 MEG sites are active worldwide, so the opportunity for substantial growth in the market is enormous. Magnetoencephalography (MEG) Functional Brain Imaging The Compumedics Neuroscan Orion LifeSpan™ MEG system is a breakthrough in MEG technology, being the first to offer adult/paediatric capability in one instrument. MEG technology highlights include: • The most accurate functional brain imaging technique currently available. It measures and localises signals using helmet-shaped arrays of super-conducting sensors in real-time at a millisecond rate with millimetre accuracy. • Completely non-invasive, safe and silent. It has a wide array of existing and emerging applications in both basic science and clinical routine. • Contributes to improved diagnostic outcomes. Data recorded from Compumedics/Neuroscan Orion LifeSpan™ MEG systems allow greater confidence in identifying areas of the brain generating epilepsy activity. This, in turn, increases confidence in surgical remediation and lead to better patient outcomes. • Increasing clinical adoption and a wide variety of research applications. These factors point to a market that will grow exponentially in the coming years. The company is strategically focused and is continuing to drive progress forward in order to allow Compumedics to appropriately capitalise on this growth. • Fully reimbursed by private and public insurance in the US, along with other countries. Compumedics/Neuroscan Orion LifeSpan™ MEG The Orion LifeSpan™ MEG is the culmination of decades of experience in the field: • An ongoing technology transfer program executed in 2016 with the Korea Research Institute of Standards and Science (KRISS), offers the field an advanced, completely integrated and significantly more cost-efficient MEG platform for both research and clinical medicine. KRISS has been developing MEG technology since the 1990s. • At the core of the new Orion LifeSpan™ MEG is the latest generation of MEG brain sensors, comprising of the patented DROS SQUID (Double Relaxation Oscillation Superconducting Quantum Interference Device). • Importantly, at the heart of the Orion LifeSpan™ MEG is a unique integrated vacuum coolant system, enabling continuous helium recycling, which not only allows 24/7 uptime for the Orion LifeSpan™ MEG, but also drastically reduces operations expenses as traditional cyclical replacement of helium for the MEG has become prohibitive in supply consistency and in cost. • This expertise, combined with the established SynAmps amplifier and CURRY® software capabilities of Compumedics, has resulted in the world’s most advanced MEG device. • The unique Orion LifeSpan™ MEG system consists of a patent pending, rotating dual-helmet dewar for adult and paediatric patients (adult/adult, paediatric/paediatric options are available). With this, two MEG systems can be contained in a single magnetically shielded room (MSR), cutting in half the cost of having two MSRs with conventional MEG systems, one for a paediatrics and one for adults. The dual-helmet design also allows a single medical centre to expand their neurological health services and associated income base, by supporting a larger patient population, from infants through to adults. Compumedics web-based sleep diagnostic platforms These eHealth developments present significant efficiency gains for Compumedics’ existing and new customers, along with a highly scalable and effective business model for Compumedics and clients, alike. Customers appreciate the industry-leading quality and sophistication of Compumedics’ “plug and play” amplifiers, coupled with the unique Compumedics single vendor solutions. Nexus™ 360 enables a fully-integrated sleep web-based platform, incorporating the first of its kind “end-to-end” clinical enterprise solution for unsurpassed simplicity and efficiency, providing an effective user clinical work flow and user experience, along with a comprehensive range of enhanced reporting tools. 9 10 Profusion Nexus™ 360 Web-Based Laboratory Management System GROWTH OUTLOOK In accordance to prior explanations, Compumedics is not looking at this global pandemic situation as a time for excuses but rather focussing on doubling our efforts to adapt and foster new initiatives applicable to these times, along with the challenges and opportunities, as we drive forward. We believe we have compensated for the slight setbacks as we work out better ways to operate, execute our focussed strategies and most importantly build our team, talent and reinvigorated focus on growth, moving forward. We look forward to sharing with the markets, in due course, our modified and adapted but sharpened strategies and initiatives designed to make up for some of the lost traction during recent pandemic lockdowns. New product platform roll-out to continue in FY21 As noted, and in accordance with Compumedics tradition of world’s best of class sleep and neuro-diagnostic monitoring systems we are pleased to be now in the final stages of preparing regulatory approvals as we prepare to release our new generation of remote monitoring EEG (Okti™), HST (“Falcon”) and continually updated Cloud services (Nexus™360) products and services for an exciting year ahead. Compumedics Falcon™ Home Sleep Testing Device Compumedics/Neuroscan expansion into much larger MEG brain analysis imaging market • The Company continues to successfully pursue further opportunities in this field during FY20 and is actively working known opportunities. Growth in international markets with active sales expansion plans for China, Japan, Germany and USA • Japan business growth led by our new partnership with Fukuda Denshi, a globally respected medical company, continues to build and grow. • Our USA team and management, coupled with a number of clients, including leaders in the area of neuro and sleep diagnostic services, have helped strengthen and position our USA business for stability and growth moving forward. • A number of our leading divisions such as DWL have already returned to overall growth, even in China, and are now leading the way in terms of both market and product diversification to already compensate for the pandemic setbacks. eHealth business expansion with continued commercial activation of its flag-ship platform, Nexus™ 360 • Having established a strong foundation with our eHealth platforms based on NeXus 360 market penetration in the USA and Australia, Compumedics is poised for international expansion in both the sleep and neurodiagnostic eHealth markets with recent installations in France, Thailand and New Zealand. • Compumedics has continually expanded the NeXus 360 installation base with over 45 sites (> 270 beds) in both the USA and Australia. • The NeXus 360 platform generated $1.13m revenue in FY20, with total signed contract value exceeding A$1.5m in annual subscription fees. • The number of patients recorded on the platform now exceeds 80,000, servicing large clients in both sleep and neurodiagnostic applications. DWL business expansion opportunities following the granting of a servo-controlled robotic ultrasound patent, along with its new generation of EZ-Dop™ technology, along with colour ultrasonic and TCD advancements • Compumedics/DWL patent, enabling a servo-controlled robotic ultrasound system. DWL produced the proof of concept for this exciting new system in the year in progress and are now rapidly moving to a clinically deployable system, expected in the year or years ahead. Compumedics are already seeking expressions of interest for collaborative partners and most importantly first-movers with DWL the original and current day founder and leader in clinically and research science deployed TCD systems. These “first-mover” reference sites include discussions with leading defence health innovators wishing to consider deployment of the new generation traumatic brain injury (TBI) and stroke diagnostic capabilities of these DWL PLL/robotic TCD systems to help save lives amongst the military personnel, ambulance service groups, emergency departments, and even leading athlete performance and health management groups, focussed and aware of ongoing TBI prevention and management. DWL® Neuro-Monitoring-Analysis (NMA) SUMMARY AND FINANCIAL OUTLOOK Compumedics remains well positioned, based on the solid overall FY20 performance, to reinvigorate growth, and indeed divisions such as DWL have already returned to growth with both new geographical market expansion, as well as existing major market growth in countries including USA and China. Moreover, the existent core business, coupled with an array of new upcoming product releases, and the continued commercialisation progress across breakout divisions such as Orion LifeSpan™ MEG and Somfit® provide a promising outlook. In particular the Orion LifeSpan™ MEG FDA market clearance, earlier this year, is a milestone commercialisation achievement, further underscoring this exciting new breakout divisions outlook. Despite margins being adversely impacted by a reduction in sales, during the temporary pandemic setbacks, the underlying profitability and efficiency measures continue in a positive direction. Return to overall growth is expected, based on Compumedics existent distribution network coupled with the excellent ongoing performance from all divisions and star examples such as DWL® prevailing and growing amidst the pandemic by way of key markets such as USA and China swiftly returning back to growth, as well as product and geographical distribution expansion initiatives. Notably, FY21 will see a number of major new product platform releases. These releases cover highly emergent growth demand for remote and telemedicine monitoring systems. Given Compumedics’ history with winning medical equipment supplier contracts, including multiple NASA monitoring contracts as well as the words largest of its kind sleep heart health study (SHHS), the company is now ideally positioned with its new generation of cutting-edge remote/telemedicine products and services. These products and services include its neuro (Okti ™), home sleep testing (HST’ “Falcon”) and continually upgraded Cloud services (Nexus360). Nexus™ 360 has cemented its foundation as a proven platform for sleep diagnostics and neuro-monitoring lab management with some significant clients on-boarded in routine, long-term and ambulatory centres. Established as a sustainable pay-as-you-go annuity (SaaS) model, Nexus™ 360 will be further augmented in FY21 and beyond with tailored feature-sets for the ambulatory (OnSight™ and Somfit®) markets. In terms of FY21 outlook guidance, the company is demonstrating strong signs, as noted, and looks forward to sharing a number of positive announcements in the year ahead. As a quick wrap-up, the FY20 was a year of staying the course and prudent management, to ensure the value of our company and our people’s jobs remained in focus throughout the temporary COVID-19 setbacks. FY21 will be a year to build on many of the new 2020 and 2021 initiatives to double our efforts on growth focus and make up for the temporary COVID-19 setbacks. However, as also mentioned we do not see the FY21 year ahead as a time for excuses, but rather a time to consolidate and strengthen our position based on very early adaptation, deployment of new initiatives of these new times of today and ahead, as well as preparing to intensify our focus and efforts towards future growth, as the restrictions of this period ease off. 11 12 All of our core business divisions have progressed and stayed the course, whilst the commercialisation progress our Orion LifeSpan™ MEG and Somfit® breakout divisions have also progressed significantly. The aforementioned upcoming new product releases, together with demands for diagnosis and health management of neuro and sleep diagnostics will continue to underpin Compumedics growth amongst its well-established direct offices and distribution partner networks for the 2021 financial year, and many years ahead. We would like to thank you all for your continued support and we look forward to driving on-going developments and associated announcements throughout the year ahead. Yours sincerely, Dr. David Burton, Ph.D. Executive Chairman and Chief Executive Officer Compumedics Limited Compumedics Okti™ ambulatory EEG paediatric back-pack GLOBAL MARKETS Global Neurodiagnostics market AUS Current Market position: 1 3 1 Competitive Advantages: 1 Complete range from clinical to research technologies 2 Uncompromised system design 3 Highest industry quality standards 4 Best in class brain analytics Current Market Share: 1% less than Key drivers: The key drivers for achieving growth in this market are to have technologically superior products that differentiate Compumedics from existing competition. This will be achieved with the revolutionary upgrade to the Compumedics EEG range that includes new class-leading hardware, user-intuitive software platforms matched with a new range of disposable consumables. Compumedics is also tapping into new EEG clinical segments such as the Home video ambulatory EEG monitoring and cortical stimulation. Current Market position: Current Market Share: AUS 1 3 1 Competitive Advantages: 1 Innovative strength 2 Active involvement in sleep science globally 3 Market placement and momentum 4 Best in class sleep analytics 6% Key drivers: To logically continue to expand our US and European sales and support infrastructure and to evolve the business to provide complete sleep medical solutions. Current Market position: Current Market Share: Description of the market: Global Neurodiagnostics is the study of electrical activity in the brain, spinal cord, nerves and muscles for the diagnosis and monitoring of neurological based diseases. Tests may be performed in hospital outpatient departments, neurophysiology labs, operating theatres, intensive care units and private practice. Global Sleep Diagnostics market Description of the market: The global Sleep Diagnostics industry is comprised of diagnostic and therapeutic technologies and medicines. Compumedics’ core business lies in the design and manufacture of technologies for the diagnosis of sleep disorders – a market estimated to be worth AUD$250 million worldwide and growing. Global Brain Research market Description of the market: Global Brain Research is the study of the brain’s functionality, using Quantitative EEG (QEEG) methods to supplement traditional EEG findings. With the advent of high speed digital information processing and statistical analysis, QEEGs extract and quantify brain electrical activity to address aspects of EEGs that cannot be appreciated visually. 1 1 1 Competitive Advantages: 1 Superior patented technology 2 Uncompromised system design 3 Unmatched innovation 4 Best in class brain analytics 30% Key drivers: The key driver for growth in brain research will be to maintain Neuroscan’s preeminent technological lead and to back this by expanding the sales and support infrastructure to harness this expanding market opportunity. Expansion into markets including animal (non-human) EEG and pharmaceutical product development will be actively pursued worldwide. Global Doppler Ultrasound market Description of the market: The Doppler Sonography technique utilises sound frequencies to measure the blood flow conditions in vessels and evaluate haemodynamics by using high- quality diagnostic and monitoring systems. DWL Doppler systems are used in a wide range of specialist branches of medicine including neurology, neurosurgery, cardio- and vascular surgery, anesthesia, intensive treatment, internal medicine, angiology and radiology. The products are purchased by private practices and clinics, hospitals (both public and private), and by major universities, national research institutes and corporate research laboratories around the world. Current Market position: Current Market Share: less than 35% Key drivers: • Highly skilled R&D team with over 25 years of experience • Diversity in TCD applications • Specific solutions for specialised applications in the use of TCD • Perfecting methods to become golden standard in TCD applications • Record number of most relevant scientific reference publications 1 1 1 1 Competitive Advantages: 1 Excellent signal and image quality 2 World best Signal to Noise Ratio 3 Product variety for monitoring application 4 Neuro-Monitoring Analysis (NMA®) 5 Emboli detection and differentiation 6 Customized Sickle Cell Disease diagnosis 7 Built in CO2 module 8 Standard, Advanced Reports and Structured Reporting (DICOM) 9 Digital interfaces 10 German quality engineering tradition CORE BUSINESS - GROWTH DRIVERS Compumedics will continue to grow its core sleep, neuro, brain research and blood flow monitoring businesses by: Compumedics / Neuroscan LTEM innovative brain analysis software (CURRY® 9 close to release) and high performance amplifiers are unrivalled world class technology. CURRY® 9 releasing in FY 21. We have >23,000 systems installed worldwide. Strong reputation and brand name. Customers like buying from Compumedics. 13 14 Earnings initiatives to continue to flow through in FY21 – FY22. New range of ambulatory products for Sleep and Neurology releasing FY21. USA based business growing with further modifications and enhancements to the team being implemented to support stronger growth across the entire business there. Continued expansion into untapped German market, and ongoing growth in France. Continuing growth from China in sleep diagnostics with a stronger emphasis on the neurodiagnostic monitoring market there. Ideally positioned to accelerate organic growth and value realisation. CORE BUSINESS Premium Focus now expanding to whole market. Compumedics has traditionally sold its products into the premium end of each of the markets it sells into. The company has recently launched, and commenced shipping, a new range of devices that have been specifically designed to be priced competitively for the majority of customers in the markets Compumedics sells into. Compumedics will use its branding and reputation in the premium end of the market to drive market expansion in the whole market, increasing the addressable market available to Compumedics by two to three times. CLIENTS AND CORE PRODUCTS Key Clients Compumedics has over 30 years of operations and in that time has worked with and established a client list of key opinion leaders, world wide which include: 15 16 Core Products Sleep Diagnostics Compumedics Grael® - 4K HD Compumedics Grael® PSG Compumedics Siesta® Compumedics Somté® PSG Compumedics ProfusionTM Sleep Software Compumedics ProfusionTM NeXus Software Neuro Diagnostics (including Brain Research) Ultrasonic Blood Flow Monitoring Compumedics Grael LT®- HD EEG Compumedics ProfusionTM EEG Software Compumedics CURRY® Neuroimaging Suite Multi-Dop® T digital Compumedics Neuvo® 512 Channel Compumedics Grael EEG® Neuroimaging Suite - 4K HD ONsightTM A.V.S. Ambulatory EEG Video Solution Compumedics Orion LifeSpanTM MEG Quik-Cap® EEG Electrode Arrays Doppler-BoxTM X FINANCIAL SUMMARY STRATEGIC GROWTH PLATFORMS The Company is focused on a number of substantial opportunities based on next-generation growth platforms applicable to DWL, Neuroscan brain imaging, and medical innovation projects such as eHealth, sleep treatment, and driver vigilance. The MEG opportunity is highlighted here. THE NEW ORION LIFESPAN™ MEG - AN EXCITING INNOVATION FROM COMPUMEDICS What is MEG? How Does it Work? Key Features Developed by David Cohen at Massachusetts Institute of Technology in the 1970s, MEG technology can record the magnetic fields associated with electric currents generated by synchronously active populations of neurons in the brain. MEG is based on the use of highly sensitive detectors called SQUIDs, or super-conducting quantum interference devices. These superconducting magnetic field detectors can accurately measure the occurrence of spontaneous brain activity called spikes, which can be signatures of the existence and location of onset for epilepsy activity in the brain such as dementia, autism and epilepsy can be detected. The development and integration of a zero-loss helium recycling system (used to cool the SQUIDs into the operational superconducting state), reduces system operating costs by as much as $100,000 USD annually. • 186/138 adult/pediatric radial gradiometers ( > Spatial Density than Elekta) • Simultaneous hyperscanning of two patients/subjects • SQUID: Double relaxation oscillation SQUID (DROS) • Average sensitivity: Better than 3.0 fTrms/ Hz (@ 10 Hz) • Integrated Zero-Loss Closed-Loop Helium Recycling • Sample Freq 10 kHz Max Option, Resolution: 16/24 bits • 32/64/128 Channel Integrated EEG • Active MSR Shielding (medium strength) • CURRY® fully integrated / STIM2 / Video Integration - Real Time Dipole Averaging and Clustering - Real Time Event Averaging - 3 CURRY® WorkStations: 1 Acquisition, 2 Analysis - multiple system configurations are under development including sitting only and combine sitting/supine options to satisfy clinicials and researcher alike. Orion LifeSpan™ key advantages Patented dual helmet rotating adult/pediatric dewar Patented Sensing System Integrated zero-loss Helium recycling Vibration-free continuous operation Helium reliquification system integrated into the Orion LifeSpan™ MEG system for reduced running costs Neuroscan MEG Neuroimaging 17 18 • The CURRY® Neuroimaging platform and MEG have a history stretching back over 30 years. CURRY was first conceived as a product in the early 1990’s when Philips Electronics investigated the feasibility of developing its own MEG hardware platform. Ultimately, the hardware platform did not survive, but the software, along with its core engineering architects, Dr. Manfred Fuchs and Dr. Michael Wagner, continued on. • The benefits associated with CURRY’s ability to integrate MEG with EEG and co-register both kinds of high-temporal resolution functional imaging data with the structural neuroimaging data including MRI, CT, DTI, as well as PET, SPECT and fMRI accelerated the adoption of the software by both the research and clinical communities. Early clinical adopters, such as Dr. John Ebersole, supported and championed the benefits of source localization tools such as CURRY, contributing to the development of specific source analysis billing codes for EEG and MEG. For a long time, CURRY has been the de-facto software platform for clinical MEG community, particularly those assessing epilepsy. This has culminated in the adoption of CURRY as the standard analysis platform by the European Epilepsy Consortium. Market & Competition • The MEG market was previously estimated at about 20 systems a year at an average selling price of USD4.0m each = US$80m/pa. The current market, anticipating the BNI instillation has adopted a wait and see state. • This is expected to grow about 10% a year, excluding China. • It is estimated that China could double the existing market size to about 70 units a year. • The dominant existing player is Elekta, based out of Sweden, but now owned by private equity, followed by Yokogawa (Japanese market not owned by Ricoh) and CTF MEG (a much smaller player). Plan • H2 FY21 – Complete installation of first sale to Barrow Neurological Institute in Phoenix, AZ, USA (COVID-19 delayed) • FY21 – Secure second sale STRATEGIC GROWTH PLATFORMS Compumedics’ cloud based sleep diagnostic platform includes a professional application, NeXus 360, and a consumer application, Somfit.® NeXus 360 has grown to over 30 sites in the USA and Australia. Laboratory Management System TM A Revolution in Laboratory Management Introducing Compumedics Profusion neXus 360, the next generation of Profusion neXus. Built on the proven Profusion neXus platform with more than 15 years of customer use and thousands of users, Profusion neXus 360 offers the full functionality of Profusion neXus and more, in a fully web-based interface. Profusion NeXus 360 Features: Platform and Browser Independent • Simple, browser/internet-based access via HTML5 • Two-factor Authentication Access • Digitally secure study “sign-off” • User-defined, group-based access privileges • Template/Document Integration • Non-editable audit-log • Multi-language Support (English, French, Chinese, Spanish) • Fully managed Cloud Service, simple installation, reliable system backups and easy system updating • In-lab acquisition and real-time uploading to the web PC / Computer Tablet Phone Quality Sleep is Essential “Every aspect of who you are as a human, every capability is degraded, impaired, when you lose sleep. What does that mean? Your decision-making, reaction time, situational awareness, memory, communication, and those things go down by 20 to 50 percent.” (Mark Rosekind, member of the National Transportation Safety Board in Sleepless in America – National Geographic Channel Documentary December 2014) 30-40% of the population 1 in 5 people Why use Gold Standard Sleep Technology? The technology in Somfit® is medically validated and the data collected is Gold standard – meaning that it is the accepted methodology to accurately measure and detect REM, and the data can be used for medical consultations with your GP if and when the need arises. 19 20 What is Sleep Fitness? Coaching Sleep fitness is getting the right type or stages of sleep and the right amount of sleep. There are five stages of sleep, each characterized by different brain activity. The most important sleep stages are REM (dream sleep) that enables brain restoration for learning and memory and deep sleep for body recovery. The body also needs alignment of our internal circadian clock with the sleep/wake cycle - otherwise sleep quantity suffers (ie the “jet lag effect”) and sleep fitness is degraded. Are you getting quality sleep (how do you know)? Movement detection is not clinically accepted as a true measure of sleep-wake. The American Academy of Sleep Medicine (AASM) recommends that to clinically and scientifically distinguish between various sleep stages to determine sleep quality or fitness - sleep scientists measure brain waves (electroencephalography or EEG), eye movements and muscle tone. This is the Gold Standard for a sleep test. The Somfit® For the first time, a fitness tracker with gold standard sleep technology. At night, the Somfit® will track your sleep collecting medical grade data to provide true sleep insights - understand your night’s sleep architecture - accurately measure the quality of your sleep through accurate measurements of durations you spend in REM, deep sleep or light sleep. Empower yourself with accurate sleep data and with Compumedics’ strong ties with the sleep professional community and extensive experience in sleep monitoring, you can take intelligent action to improve your wellbeing and performance. Who is it for ? • Athletes - managing and enhancing performance • Diabetics • Medical professionals - to assist treatments of insomnia or depression • Anyone who wants to truly understand their sleep habits for well being. The power inside START STUD Y Somfit® coaching APP Powered with technologies from Compumedics, the company with over 30 years experience in professional sleep diagnostics and equipping leading sleep laboratories around the world with advanced sleep monitoring systems. Compumedics offers expertise in medical product design, but significantly provides the advanced diagnostic-grade signal processing power for more accurate sleep staging and analysis in the Somfit.® A FOCUSED STRATEGY IN ACTION For over 30 years, Compumedics’ focus in Sleep and associated medical disorders has established a solid platform for growth. Used by NASA and SHHS. S-Series – (cid:87)(cid:75)(cid:72)(cid:3)(cid:192)(cid:85)(cid:86)(cid:87) digital sleep system in (cid:36)(cid:86)(cid:76)(cid:68)(cid:3)(cid:51)(cid:68)(cid:70)(cid:76)(cid:192)(cid:70) P-Series and S-Series released Compumedics announced the release of the P-Series Portable Sleep Monitoring System with features including intelligent CPAP control. Compumedics established Dr. David Burton founded Compumedics to design and manufacture medical electronics. Prior to Compumedics, analysis and diagnosis depended, in large part, upon manual recording methods, which were very time consuming and costly to implement. NASA contracts won for International Space Station and Space Shuttle flight preparation NASA chose Compumedics’ P-Series Portable Sleep Monitoring System for the 1998 Neuro-mission Space Shuttle flight preparations. Compumedics won the contract to supply medical hardware for the International Space Station’s Human Research Facility (HRF) under contract to NASA. Compumedics recognised Compumedics was named Australian Exporter of the Year. Compumedics was awarded the 1998 Governor of Victoria Award for Victorian Exporter of the Year. Compumedics was awarded the 1998 AusIndustry Innovation Award. Compumedics was awarded the 1998 Telstra Innovation Award. Compumedics DWL awarded membership to Germany’s top 100 innovative companies. Compumedics awarded the 2006 Frost & Sullivan Technology Leadership Award. Compumedics and chairman inducted into the Victorian Manufacturing Hall of Fame. Somté® PSG is released - the simplest and most convenient way to meet requirements for recording full PSG, in both attended and unattended settings. Siesta 802™ World Siesta 802™ – World leading wireless system for sleep and EEG - receives FDA clearance. Somté® PSG - Full PSG absolutely anywhere. 1988 1993 1994 2001 2006 - 2008 2009 1987 1991 1995 1998- 1999 2000 2002- 2005 Compumedics’ ASX listing Compumedics listed on the Australian Stock Exchange. Compumedics’ completes first acquisition – Neuroscan. Grael® is released - Compumedics released the world’s first High Definition and premier PSG/EEG, Grael.® Grael® wins Powerhouse Museum Award & finalist at the Australian International Design Award. Epworth installs first Sleep Disorders Unit Compumedics’ first sleep system was installed at the Epworth Hospital Sleep Disorders Unit (Melbourne, Victoria). TIME magazine and the television series ‘Beyond 2000’ both featured the Epworth sleep center. $1.7M Sales split Domestic $1.5m Export $0.2m Chosen for world’s largest sleep study Compumedics won the competitive US Government- funded contract to supply the equipment for the world’s largest sleep study (6000 patients). The five year Sleep Heart Health Study (SHHS) was won against a field of 22 competitors, including multinationals. Compumedics supplied 40 P-Series Sleep Monitoring Systems along with 9 replay and 6 analysis systems. The equipment selection committee was made up of sleep experts from 11 leading University Hospitals across the USA. Compumedics was granted IEC 601-1 patient safety certification for its S-Series and P-Series products. E-Series EEG/PSG system DWL division established for blood-flow Doppler technology. technology. Grael® PSG/EEG (cid:16)(cid:3)(cid:58)(cid:82)(cid:85)(cid:79)(cid:71)(cid:183)(cid:86)(cid:3)(cid:192)(cid:85)(cid:86)(cid:87)(cid:3) (cid:43)(cid:76)(cid:74)(cid:75)(cid:3)(cid:39)(cid:72)(cid:192)(cid:81)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3) (cid:36)(cid:80)(cid:83)(cid:79)(cid:76)(cid:192)(cid:72)(cid:85)(cid:17) Compumedics introduces direct selling in Germany. Globally read TIME magazine cover and article brings the “Trouble with Sleep” to the world. Sales revenue $20.2M Beijing Bestmed, Compumedics’ China- based distributor invests $0.5M, becoming a top 10 shareholder - this injection of funds contributes to Compumedics further growth in the China region. region. Compumedics recognised as one of Australia’s top 100 Health Innovators through its world leading devices for eep diagnostics. sleep diagnostics. Somnilink SPAP® Somnilink SPAP receives CE and TGA clearance. New Patent Grant Underpins Growth Opportunities for Compumedics’ DWL. - New product development based on patent for system of detecting and treating blood vessel stenosis or occlusions. Compumedics Announces Successful MEG Installation at BARROW NEUROLOGICAL INSTITUTE Compumedics wins major multi-million dollar MEG brain imaging contract. 21 22 New products released - NEW Neuroscan Quik-Caps Now in Gel-based Electrode Arrays in Neoprene and Silicone and Liquid-Electrolyte Hydro Net Arrays. CURRY® SCAN 7 Neuroimaging Suite is released Compumedics introduces direct selling in France. ® Neuvo® LTM 512 Channel EEG $7.5 Million Sleep Diagnostic Systems Contract with Beijing Bestmed Accelerates Compumedics Strength in China. Growth in China - Compumedics confirms strength in China with over $5M in sales in 2017. New product released - Profusion NeXus 360 - A Revolution in Laboratory Management. 2010 - 2011 2012 2013 2015 2017 2019 2014 2016 2018 2020 ehealth Business focus in Asia. New contract signed with Bestmed (China) with potential revenue of US$5 million over the next three years growing to US$13.2 million within five years. Company has now secured total contracts for its eHealth platform with potential incremental revenue of US$9.1 million over the next three years. New products released - Profusion EEG5 - World class EEG diagnostic software. Profusion Sleep4 - World class PSG diagnostic software. 25 YEARS OF DIAGNOSTICS EXCELLENCE Compumedics celebrates its 25 Year Silver Jubilee Anniversary. Neuvo® LTM, world’s first 512 channel wall system is released to market - the Ultimate Long-term Monitoring System. Grael®-HD EEG - High-Definition EEG is released to market. Grael®-HD EEG Grael® PSG Grael® LT EEG New Grael® Range released for market - Grael® PSG, Grael® LT and updates to Grael® and Grael® EEG New e-Health Somfit® consumer product is developed - (cid:54)(cid:82)(cid:80)(cid:192)(cid:87)® Night Compumedics and KRISS (Korea Research Institute of Standards and Science) officiates technology transfer agreement and MOU for new advanced MEG. Successful completion of $6.5M capital raising Compumedics Signs $3.6 Million Distribution Agreement with Fukuda Denshi Co., Japan Fukuda Denshi Co. becomes Compumedics’ new neuro diagnostic distributor in Japan. The deal further underpins Compumedics’ on-going growth in Asia and opens a new market for Compumedics existing product range – neuro-diagnostic and monitoring products – in Japan. New product released - ONsight™ A.V.S Ambulatory Video EEG Solution Monitor your patient’s home ambulatory studies with CONFIDENCE! EEG with Video recording in “Real Time”! New products released - CURRY® 9 - Compumedics Neuroscan releases the latest in the CURRY® Neuroimaging Suite. ProFusion Sleep 5 & EEG 6 Latest generation ProFusion Software suite for PSG and EEG updated with even more user- friendly features and functionality. BOARD OF DIRECTORS Compumedics is committed to developing a world class working environment that rewards individuals for the contributions they, and their teams, make to the business each year. Compumedics is proud of the diversity of its people, and continues to develop its people infrastructure under the guidance of the Senior Management Team and the Board. Dr. David Burton, Ph.D. Executive Chairman, CEO Dr. David Burton, Ph.D., is the founder, Chairman and CEO of Compumedics. After establishment of Compumedics the company was listed on the ASX in 2000, and has been awarded 24 awards for design, innovation, business and exports including the Australian Exporter of the Year in 1998 and Small Business of the Year in 1999. Dr. Burton started his career at the Bureau of Meteorology, where he studied radar techniques and electronic equipment. He founded Linear Transfer Pty Ltd, which designed, manufactured and marketed high fidelity recording and sound equipment. He was awarded an Associate Diploma in Engineering (Electronics) by the Royal Melbourne Institute of Technology and a Ph.D. (Eng. Sc.) by Monash University, Melbourne (Australia). Dr. Burton’s engineering background includes the design and project management of Compumedics’ first sleep laboratory and portable sleep systems. Dr. Burton has authored 150 patents or patent applications across more than 20 families of patents that form part of Compumedics’ intellectual property. Dr. Burton has served as an advisor for the Victorian Government as a member of the Council for Knowledge, Innovation, Science and Engineering (KISE), being the Victorian Government’s key advisory body on issues and policies focusing on science and innovation. Dr. Burton was presented the Clunies Ross National Science and Technology Award in 2002 for his development of innovative sleep monitoring technology. He was awarded the 2003 Centenary Medal by the Prime Minister and Governor General of Australia for outstanding contribution to science and technology, particularly public science policy. In 2003 Dr. Burton was awarded the Ernst & Young Victorian Entrepreneur of the year award for technology, communications, E-commerce and life sciences. In 2007 Dr. Burton was inducted into the Victorian Manufacturing Hall of Fame in recognition of manufacturing achievements and world-wide medical device exports. Dr. Burton served as a Victorian Government adviser as a Board member of the Design Victoria (2008-2011), was appointed to the Academy of Technological Science and Engineering (ATSE) committee in 2012 and in recognition of his outstanding contribution to the profession of Biomedical Engineering and was awarded the 2012 David Dewhurst Award by Engineers Australia, College of Biomedical Engineers. Mr. David Lawson Executive Director Mr. Tucson Dunn Non-Executive Director Mr Lawson has been Chief Financial Office and the Company Secretary of the Company for over nineteen years. In that time, Mr Lawson has been extensively involved in the development of the Company including the Initial Public Offering of shares in the Company, the subsequent offshore acquisitions in the US and Germany, private equity placements and the recent refinancing of the Company. Mr Lawson also has been involved in the operational turn around of the Company and brings a significant amount of experience and knowledge to the Board. Currently working with JLM Investment, (USA) as CEO of Healthcare where he is responsible for healthcare ventures. Prior to joining JLM, Mr. Dunn served as Managing Director of Fosun Healthcare Holdings in Shanghai China. Mr. Dunn has over 25 years of international healthcare leadership experience developing and managing hospitals, clinics and related business throughout Asia, Middle East, Europe and USA. SENIOR MANAGEMENT Dr. David Burton, Ph.D. Executive Chairman, CEO David Lawson Executive Director, Chief Financial Officer & Company Secretary 23 24 Warwick Freeman Chief Technology Officer Christoph Witte General Managing Director DWL Compumedics Germany GmbH Your World of Sleep and Neuroscience World-Class Sleep Software Web-based From Clinical to Research World-Class Neurology & Brain Research Software 25 26 www.compumedics.com O V E R T H I R T Y AI463-0
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