CANARY BIOTECH & HEALTHCARE INVESTOR ROADSHOW

Transcription

1 CANARY BIOTECH & HEALTHCARE INVESTOR ROADSHOW Wednesday 8 July 2015: isonea will be presenting at the Canary Biotech & Healthcare Investor Roadshow to be held on Wednesday 8 th July in Melbourne and Thursday 9 th July in Sydney. The investor presentation is attached and the key messages for new investors are outlined below: Unique first mover advantage with its proprietary ARM technology to detect and measure wheeze A multi-product portfolio in respiratory health not based on one product and thus lower risk for investors. Core technology that has been used by world leading respiratory physicians and scientists. Forefront of digital/mobile health platforms that will change asthma care Huge global market with over 300 million people with asthma Asthma is a global burden for health systems Business turnaround by new Board and Management team Clear pathway forward to monetise the business Valuation potential Substantial transactions starting to occur in digital health Leon L Huillier Chairman +61 (0)

2 World s First Digital Wheeze Detection Technology for the Management of Asthma An Australian owned company with Israeli & Australian technology 1

3 Changing Asthma Care About isonea World s First Digital Wheeze Detection Technology for the Management of Asthma isonea is a medical device company with an innovative portfolio of wheeze detection & measurement products that help patients & physicians improve asthma management and reduce preventable emergency room visits, hospitalisation & unnecessary worry & suffering. isonea has unique leading edge acoustic sensors, proprietary algorithms and software platforms to objectively detect and measure wheeze, an important symptom of asthma. Its latest product, AirSonea, is a remote patient monitoring device and app. 2

4 Why investnow? now? Why The company is now well positioned to create shareholder value and has substantial value creation potential: Unique first mover advantage with its proprietary ARM technology to detect and measure wheeze A multi product portfolio in respiratory health not based on one product and thus lower risk for investors. Core technology that has been used by world leading respiratory physicians and scientists. Forefront of digital/mobile health platforms that will change asthma care Huge global market with over 300 million people with asthma Asthma is a global burden for health systems Business turnaround by new Board and Management team Clear pathway forward to monetise the business Valuation potential: Substantial transactions starting to occur in digital health 3

5 Have you noticed you ve been wheezy, breathless or coughing lately? Are you using your medication more? Is your asthma interfering with you usual activities? Asthma Australia Spring 2014 Update 4

6 Changing Asthma Care Asthma Symptoms The main symptoms of asthma: Wheezing Shortness of breath A tight chest Coughing Airflow Limitation When airways become inflamed, flow pressure changes during respiration causing the airway wall to flutter. This flutter results in acoustic energy, or wheeze. The flutter or wheeze is a manifestation of airway flow limitation. If an infant presents with frequent and/or severe episodes of recurrent wheezing they should be diagnosed and managed as asthma, unless there is evidence to the contrary. Global Asthma Report

7 First Mover Advantage/Computerised Wheeze Detection isonea continues to have a first mover advantage with its unique proprietary Acoustic Respiratory Monitoring(ARM ) algorithm technology. Our ARM technology records airway sounds to detect continuous adventitious breath sounds and measure the extent of wheezing caused by airway obstruction. The measurement is presented as WheezeRATE. isonea devices work like a stethoscope utilising special contact microphones, or acoustic sensors, to pick up breath sounds from the lungs at the windpipe(trachea), and in the clinical devices, the chest. Actual wheezing event from an asthma patient, recorded with isonea s ARM technology. 6

8 A Multi-Product Portfolio to Lower Risk for Investors The company s portfolio of computerised wheeze detection products and apps AirSonea, WHolter, SonoSentry, WheezoMeter, PulmoTrack and the AsthmaSense App Have been approved by the Australian TGA and carry the European Union s CE mark. All except AirSonea have US FDA clearance 7

9 Remote (Home) Monitoring Products Health authorities universally agree effective tools to improve patient self-management of asthma are critical. AirSonea Asthma Wheeze Monitor Device& App The convenient and easy-to-use AirSonea device connects via Bluetooth with the asthma management smartphone app to detect and measure wheeze. The 30 second recording and WheezeRATE algorithm analysis takes place within the app with measurements results displayed on the smartphone screen. The results and actual sound files are automatically uploaded to the cloud servers so the entire history can be reviewed and shared with doctors and other healthcare providers via secure . The app features asthma management diary features; medication usage and reminders, and symptoms and triggers to help asthma sufferers gain a better understanding of how their condition affects them and importantly, help them better adhere to their treatment plans. Further features including weather conditions and pollen count are planned. The development of robust acoustic devices for use at the bedside as exemplified by electronic stethoscopes paired with small convenient recorders and perhaps in the form of a smartphone with an app - may provide the long-awaited portable objective means to record, analyse, and store lung sounds just as any other clinical information is measured and stored. This development will make sound tracking possible, further enhancing the usefulness of auscultation. Fundamentals of Lung Auscultation by Abraham Bohadana, M.D.Gabriel Izbicki, M.D. &SteveSKramanM.D.New England Journal of Medicine 370;9 NEJM:ORG FEBRUARY 20,

10 Remote (Home) Monitoring Products SonoSentry 1 (WheezoMeter ) and New SonoSentry 2 Prototype. Standalone device with inbuilt LCD screen. isonea has achieved the first clearance of an Overthe-Counter (OTC) wheeze detection device in the United States. With FDA clearance, the company can market the device in the USA as an OTC product without the need for the purchaser to obtain a prescription from a medical practitioner. Computation is performed on the device and a phone, phone service or a server is not required (however, there is additional value in being able to extract information from the device to be placed onaserver). isonea is actively investigating the potential to substantially lower the costs of production of SonoSentry 2 to evaluate a commercial launch of this product in China and developing countries. 9

11 Home Monitoring: Nocturnal WHolter Symptoms of asthma, including wheeze, are generally worse at night and early morning. TheWHolterisdesignedfor8-24hourhomeambulatory recording (nocturnal, wheeze, cough). This option of monitoring Asthma patients and collecting data for a period of time in their own home is important and has excellent potential to develop service and consumables revenues around it. WHolter uses PulmoTrack software andcurrentlyconnectstoapcviausb. Next Step: upgrade to wireless capability and app function 10

12 Clinical/Hospital Monitoring PulmoTrack Wheeze Detection Computerised PulmoTrack is isonea s foundation product, designed for hospital/clinic-based real-time monitoring of wheeze and cough in the management of acute, severe asthma in the ER and IC, and for Pediatric Pulmonary Function Testing and Sleep Labs. The PulmoTrack module has a wireless connection toapc. In a recent study conducted at the Department of Neonatology, Charité University Medical Centre, Berlin, Germany, wheezes were detected using the PulmoTrack Model an instrument developed for continuous tracking and recording of breathing sounds and the detection of wheezing. Computerised wheeze detection is feasible during the first year of life. This method is more objective and can be more readily standardised than subjective auscultation, providing quantitative and noninvasive information about the extent of wheezing. Puder et al BMC Paediatrics

13 Core ARM Technology Research Published by World leading Physicians History of 14 clinical publications, using isonea s proprietary Acoustic Respiratory Monitoring(ARM ) technology. ORIGINAL ARTICLE JOURNAL OF ASTHMA Vol. 41, No. 8, pp , 2004 Wheeze Detection: Recordings vs. Assessment of Physician and Parent M. L. Levy, 1,4,* S. Godfrey, 2,# A. Sheikh, 4 W. Hanekom, 5 Ambulatory Care Nurses, 5 A. Bush, 6 and P. Lachman 1. Kenton Bridge Medical Centre, London, UK 2. Hadassah University Hospital, Jerusalem, Israel 3. Karmel Medical Acoustic Technologies Ltd., Yokneam Ilit, Israel 4. Division of Community Health Sciences, GP Section, University of Edinburgh, Edinburgh, Scotland 5. Northwick Park Hospital, London, UK 6. Royal Brompton Hospital, London, UK 12

14 Globally Renowned Physicians Speak at Asthma Conferences Two of the globally renowned physicians who have published on wheeze detection were keynote speakers at recent major asthma conferences held in Australia during 2015 Professor Andrew Bush Dr Mark Levy Professor Andrew Bush Professor of Paediatric Respirology, Royal Brompton Hospital, NHS Foundation Trust. Faculty of Medicine, National Heart and Lung Institute. DrMarkLevy Respiratory lead for the Harrow Clinical Commissioning Group in Harrow, London. Senior Clinical Research Fellow, University of Edinburgh( ). 13

15 isonea s Medical & Scientific Advisors are Internationally Respected Professor Noam Gavriely, MD, D.Sc He has been conducting basic and applied research on pulmonary acoustics for over 25 years and is an international authority in this field. He is extensively published in various aspects of breath sounds, including the 1995 CRC press book on "Breath Sounds Methodology", and holds multiple US and international patents on phonopneumography and other aspects of breath sounds monitoring. Dr. Gavriely received his M.D. and D.Sc. from the Technion-Israel Institute of Technology and did his postdoctoral fellowship at the Harvard School of Public Health and the Brigham and Women s Hospital. Prof. Simon Godfrey, MD, PhD, FRCP, FRCPCH is Emeritus Professor of Pediatrics at the Hadassah-Hebrew University, Jerusalem. His major clinical interests are in pediatric pulmonology and asthma. His main research interests are in pediatric pulmonary physiology, infant lung function, asthma, bronchial provocation and the application of novel investigative techniques for the diagnosis and management of pediatric pulmonary diseases. Prof. Godfrey has published over 190 original papers, 16 books and contributed numerous chapters to other books, in addition to written editorials on pediatric pulmonary topics. 14

16 isonea at Forefront of Explosive Field of Digital Health First wave: Fitness and wellness devices The first wave of this trend is already evident in the rapid consumer adoption of wearable sensors and smart watches which produce data related to physical activity, although of limited or little clinical value. Second wave: Digital health platforms for complex diseases The second wave includes the monitoring of symptoms and behaviour in chronic disease management, such as wheeze detection and measurement in asthma, glucose monitoring for diabetics. Thirdwave:Bigdata The third wave will come with algorithms and software that can sense and interpret multiple factors and conditions that could impact symptoms, in order to identify risks and issues alerts for avoidance. This aspect involves the collection and analysis of Big Data from multiple sources, including the networks of device users. 15

17 Remote Patient Monitoring: Key Driver of Growth Smartphones provide an engine for this change: It is estimated that there will be 10 billion mobile devices in use worldwide by We're all essentially surgically connected to our smartphones, and we're still in the early stages of realising their medical potential. Dr. Eric Topol, Director, Scripps Translational Science Institute #1 Most Influential Physician Executive in the USA, Modern Healthcare National Poll Health conscious consumers are already embracing self-management and this is evident in the growth of wearable fitness sensors such as Fitbit. The continued shift toward accountable care will encourage the adoption of remote patient monitors for chronic diseases like asthma, diabetes and cardiovascular illness, with the goal of keeping patients out of the hospital, lowering costs and improving care. 16

18 Digital Health Platforms Replace Outdated Technology Respiratory Digital Health: Asthma & COPD Sensors, apps, text and analytics to monitor and control symptoms. Convenient, effortless, objective symptom measurement - isonea Traditional Monitoring Peak Flow Meters Outdated technology, not suitable for children, patient compliance poor and considerable patient effort. isonea has broad patents that could provide barriers to entry 17

19 Huge Global Asthma Market 334 million people have asthma 14% of the world s children experience asthma symptoms 8.6% of young adults (aged 18-45) experience asthma symptoms Approximately 250,000 people die prematurely each year from asthma. Almost all these deaths are avoidable (WHO 2007) China: Over 30 million but probably closer to 100 million USA: 25 million, 10% of children Europe: 30 million UK: 5 million Australia: 2 million 18

20 Asthma is a Major Health Burden Theasthmaburdentosocietyismassiveintermsofasthma deaths, hospitalisation, emergency visits, missed days of schooling and work. IntheUSA,forexample: 5,000 deaths per annum 2 million emergency department visits 500,000 hospitalisations 27millionmisseddaysofschoolandwork Createsaburdencostofover$56billionannuallyor$2,200 per person including both the direct and indirect medical expenses associated with asthma, it is estimated that the total cost is closer to $82.5billion annually, or $3,300 per person. Source: US department of Health and Human Services CDC

21 Asthma is Poorly Controlled and New Tools are Essential Asthma is poorly controlled and new tools are needed to help patients. Nearly half of adults with asthma in Australia had poor asthma control and 29% needed urgent health care for asthmainthepreviousyearaccordingtoarecentstudypublishedinmedicaljournalofaustralia. 3 49%ofthepeoplewhohaddiedintheUKfromasthmain2012werebeingtreatedformildormoderateasthma whenitislikelythatmanyofthesepatientshadpoorlycontrolled,undertreatedasthma. 4 48%ofadultsdiagnosedwithasthmawhoweretaughthowtoavoidtriggersdidnotfollowmostofthisadvice 5 Medication adherence is poor. Data suggests approximately 30% of patients do not take their medications as prescribed. Although written asthma action plans have been recommended in national guidelines for the management of asthma for over 20 years,themajorityofpeoplewithasthmadonothaveone. Asthma in Australia 2011 The Australian Centre for Asthma Monitoring, Woodcock Institute of Medical Research 1. Centers for Disease Control and Prevention (CDC) : Asthma Statistics/Asthma Society of Canada, 2. Global Asthma Network: Global Asthma Report Medical Journal of Australia 202 (9) 18 May 2015: Asthma control in Australia: a cross-sectional web-based survey in a nationally representative population 4. Why Asthma Still Kills, The National Review of Asthma Deaths (NRAD) May Centers for Disease Control and Prevention, Vital Signs, May

22 Market Research: AirSonea an Important Management Tool isonea has conducted extensive market research in the US and Australia that shows our functional, user friendly product line will meet the expectations of our customer base that includes parents and patients, the medical profession, insurers, pharmacies and retailers. Key Findings: Parents Parents of children with asthma are constantly worrying about their child s health and wondering when the next attack will occur and what will trigger it. Theyadmittheycouldbemorediligentandnonefeelliketheyareincompletecontrol. They also find it difficult to articulate the severity of symptoms. Asthma Guilt is pervasive. It s a function of the pressure of day-to-day life overwhelming the best of intentions; coupled with the more reactive approach to an asthma attack rather than proactive management. They also find it difficult to articulate the severity of symptoms to doctors, a source of some frustration. Adults Adults with Asthma (secondary market) have more established knowledge of their asthma and know if I m wheezing or not. Certainly interested but not to the same degree as parents. 21

23 Key Findings: Medical Professionals Medical Professionals Interest in device: Intent to purchase the AirSonea wheeze monitoring device ranged from 60%to95%inthevariousstudies. isonea also conducted qualitative in-depth interviews with key asthma experts and a quantitative study with a total of 100 Australian GPs including 50 Paediatricians who routinely treat asthma. Results found that 80% of GPs and 62% of Paediatricians in the study would recommend isonea s new mobile wheeze monitoring system to their asthma patients. Providing additional scientific data on the technology would increase the percentage of these recommendations. In general, the product was perceived as an important management tool for patients who would benefit form more frequent home monitoring of asthma symptoms, which were characterised as 75% of patients with unstable asthma and approximately half of all patients with stable asthma. Physicians considered home monitoring of asthma very important, chiefly to assist in the management of asthma treatment plans and ensuring medication adherence. They noted that historically, the use of peak flow meters and diaries has been met with poor compliance and reliability. *The Independent consumer research studies were conducted by Dectiva LLC, Procter & Gamble Tremor, Galaxy Research, Consilium and Sweeney EY Research 22

24 Business Turnaround by New Board & Management Team The new Board appointed in February 2014 has delivered major changes to turnaround the business 1. The business structure has been dramatically simplified, costs reduced and streamlined for clearer focus 2. A totally new software IT infrastructure has been developed to support the AirSonea device and app. 3. Cashburnreducedfromnear$900,000pmtoaforecastcoreunderlyingcashburnofaround$240,000pm. 4. Intellectual Property Portfolio consolidated 5. Leading globally respected scientific advisors appointed 6. Improved relationships with leading clinicians, healthcare professionals and peak Asthma bodies established 7. Broader focus on the whole portfolio of products to open up substantially more commercial opportunities 23

25 Business Turnaround by New Board & Management Team The new Board appointed in February 2014 has delivered major changes to turnaround the business 1. Overall, the business structure has been dramatically simplified, costs reduced and streamlined for clearer focus and accountability and more robust financial controls Management are now based in Melbourne, Australia and Haifa, Israel. Senior Management previously resided in multiple locations including Maryland, Boston, San Diego and New York $2.5 million pa taken out of management and staff costs 2. A totally new software IT infrastructure has been developed to support the AirSonea device and app. Our new software is more robust, scalable and secure. Micro-processing upgrades have addressed firmware bugs. Further, it provides substantially faster analysis of breath recordings and an app with a more engaging user interface. The failed launch in Australia indicated web and app problems and the engagement of multiple service providers situated on four continents resulted in a high cost, over-engineered and incomplete IT infrastructure. 24

26 Business Turnaround by New Board & Management Team 3. Cash burn reduced from near $900,000 per month to a forecast underlying burn of around $240,000 per month. Estimated cash balance of $2.9 million as at June 30*. Net average monthly outgoing cash flows ($000) 881 High R & D spend * Prior to finalisation of Quarterly 4C statement. Forecast underlying cash burn 25

27 Business Turnaround by New Board & Management Team 4. Consolidated Intellectual Property Portfolio: One service provider to ensure our patent strategy is implemented and that our IP is secured in relevant jurisdictions. 5. Appointed leading globally respected scientific advisors: Prof Noam Gavriely& Prof Simon Godfrey 6. Established improved relationships with leading clinicians, healthcare professionals and peak Asthma bodies in Australia and overseas. 7. Broader focus on the whole portfolio of products to open up substantially more commercial opportunities in both the home/ambulatory market and in hospital and clinical settings. 26

28 isonea Current Partnerships Shartsis Friese LLP, USA Patents FAL Lawyers Australia EY Sweeney Market Research DKC Consultants Finance & Accounts Sterling Medical QA USA isonea Board Executive Chair isonea Israel R&D, Medical & Scientific Advisory The Wall Partnership User Interface R&D Marketing Refined Manufacturing China Two Bulls App Development Life is Digital Web/ hosting Grey Innovation Product Development 27

29 Clear Pathway Forward Building shareholder value through global and country partnerships either as joint ventures or sales and distribution agreements remains our core objective. Our pathway forward is two-fold and these steps are being managed in parallel 1. Commence commercial discussions with potential partners that include the worlds largest healthcare companies 2. Complete clinical trials on AirSonea overseas, especially in the important North American market 28

30 isonea brings Digital Health Capabilities to Worlds Largest Healthcare Companies Fitness & Wellness Devices Thermometer Weight Scale Step Counter Pulse Oximeter Heart Rate Monitor Blood Pressure Monitor Baby Monitor Chronic Disease Devices AirSonea Wheeze Monitor Smart Inhalers Blood Glucose Monitors Cardiology Patient Self- Management Smartphone Personal Computer Personal Health Diary Internet Healthcare System Family Carers Disease Management Hospitals & Healthcare Providers Insurance Companies isonea Potential Partnerships Medical Devices & Disease Management Philips, Omron, ResMed, GE Healthcare, CareFusion, Vectura, Propeller Health, Alere, Care Innovations, Dexcom, Withings Big Pharma GlaxoSmithKline, AstraZeneca, Schering-Plough, Boehringer Ingelheim, Novartis, Teva, Smartphone/Portable Health Devices Apple, Samsung, Xiaomi, Sony, Fitbit, Jawbone, ihealth Labs TeleHealth AT&T, Verizon, Telstra, Optus Digital Platforms Microsoft HealthVault, Qualcomm, Neusoft, Google, Yahoo 29

31 Complete Two AirSonea Clinical Trials Trial 1: The objective is to show AirSonea is at least as accurate as a consensus of a panel of physicians and trained experts in detecting and quantifying wheeze. In the last few years, 14 successful clinical studies have been conducted using isonea's proprietary ARM technology on patients with obstructive airway disease. Trial 2: Theobjectiveistostudytheefficacyofmanagingasthmainchildrenduringandafteranacuteattackusingthe AirSonea device to measure wheeze rate in an Urgent Care/Emergency Department setting. The company expects Trial 1 to be completed by the end of October and Trial 2 by year end. However, the number of variables in clinical trials make it difficult to accurately predict completion dates. 30

32 Valuation Upside: Transactions Now Occurring Wellness Devices Fitbit: IPO: $8 Billion Valuation. New fitness & wellness product Fitbit Surge tracks GPS, continuous heart rate, all-day activity stats and sleep, September Xiaomi: ihealth s small wellness business valued at over $125million. Asian smartphone giant, Xiaomi buys 20% stake in Andon s ihealth business for $25 million 31

33 Dexcom Complex Disease Device Dexcom market cap now $5.6 billion Dexcom Introduces Apps That Enable the First Ever Continuous Glucose Monitoring (CGM) on the Apple Watch Now People With Diabetes and Caregivers Have Access to Life-Saving Glucose Data in a Convenient and Discreet Manner Right from their Wrist Dexcom continuous glucose monitor (CGM) provides patients the opportunity to track their glucose levels and trends right on their wrist with the Apple Watch. Additionally, patients or "Sharers" can invite up to five people to view their glucose information and send an alert when the sharer's glucose levels are outside the norm. Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years. Dexcom Stock Check 32

34 ResMed Complex Disease Device ResMed buys Irish Company, S+ in 2011 and launches consumer product in America in Peter Farrell: We have a consumer app and device called S+. It tracks every breath, gives you your sleep history. This is a consumer product. It was written up in The Wall Street Journal as the best. We ve sold thousands. Itwillbeherein2015. The S+ monitors breathing patterns and body movements without requiring uncomfortable wristbands, mattress strips or electrodes. The system allows consumers to log factors such as caffeine and alcohol intake, as well as exercise, to analyze patterns over time and deliver personalized sleep strategies. The capabilities of the S+ go beyond those of fitness devices available on the market because the S+ algorithm provides personalized suggestions informed by more than two million nights of proprietary sleep data. 33

35 Forward Looking Statements & Medical Device Risks Forward Looking Statements Certain statements made in this presentation are forward-looking statements. These forward looking statements are not historical facts but rather are based on isonea s current expectations, estimates and projections about the industry in which isonea operates, and its beliefs and assumptions. Words such as "anticipates," "expects," "intends,""plans,""believes,""seeks, "estimates, guidance and similar expressions are intended to identify forward looking statements and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the control of isonea, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward looking statements. isonea cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of isonea only as of the date of this presentation. The forward looking statements made in this presentation relate only to events as of the date on which the statements are made. isonea will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority. General Medical Device Risks Medical device R&D involves medical and scientific uncertainty and long lead times and there is no certainty that any particular event will occur within a certain time period. Technology changes in the medical device and digital health industry are accelerating and new technologies emerge. Market acceptance of medical devices is uncertain and can be impacted by difficulties in marketing, acceptance by patients and clinicians, delays in marketing and the advancement of new competitive products. Medical device R&D and manufacturing activities require funding over a long period of time and more working capital is often required to complete development and commercialisation of certain products. Government health regulations, which are subject to change, add uncertainty to obtaining approval to market medical devices. Obtaining, securing and maintaining rights to technology and patents are an integral part of securing potential product value and can lead to patent disputes. Thelossofkeypersonnelcanhaveanadverseimpact. Potential product liability risks and warranty claims are inherent in the manufacturing, marketing and use of human medical devices. 34

36 APPENDIX 35

37 Brief Company History Appendix APPENDIX isonea Limited (ISN) is an Australian owned, public company listed on the ASX. It is a developer, manufacturer and marketer of medical devices for the diagnosis and management of asthma and related chronic respiratory diseases. Brief History : Company Beginnings In 1996 Prof Noam Gavriely M.D. D.Sc. founded company Karmel Medical Acoustic Technologies (KMAT) in Haifa, Israel. The company s technology was based on innovations in the field of pulmonary acoustics developed by Prof Gavriely. His translation research applied the basic physics of sound into medical and nursing practice to enhance health outcomes and patient wellbeing. In 2006, KMAT (Israel) and Pulmosonix (Australia) were purchased by Salus Technologies, a listed Australian company. The group was renamed KarmelSonix Ltd. In 2011, the company name was changed to isonea Limited and a new Board of Directors and an American management team were appointed :AmajorstrategicerrorinSeptember2013 A major strategic error was made in 2011 with the decision to rush the design, development, manufacture and launch in Australia of a portable monitoring device, the AirSonea Asthma Wheeze Monitor and App. Successful FDA cleared clinical products were discontinued and the relationship with the foundation professors in Israel terminated. The September 2013 online launch failed. The hype around smartphones and mobile health applications gave investors unrealistic expectations of early success. The product had poor user experience and functionality, no brand recognition nor support from the medical profession and the broader asthma community. This expensive and ill-conceived online launch in September 2013 had a serious impact on the company s financial and cash position as sales revenue of only $19k resulted. 2014: Company Turnaround The company s financial position was deteriorating rapidly and a new commercially experienced Board was appointed. The Board now comprises of : Mr. Leon L Huillier(Executive Chairman), Mr. David Ashmore, Mr. Ross Blair-Holt, Dr. Timothy Oldham and Mr. John Ribot-de-Bresac. 2015: Appointed the company s original medical and scientific leaders, Prof Noam Gavriely as consultant and Emeritus Prof Simon Godfrey as Senior Scientific Advisor. 36