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Itamar Medical Ltd Investor Presentation January 2014.

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Presentation on theme: "Itamar Medical Ltd Investor Presentation January 2014."— Presentation transcript:

1 Itamar Medical Ltd Investor Presentation January 2014

2 Disclaimer (c) Itamar-Medical This presentation is not an offer to buy or sell securities of the company or an invitation to receive such offers, and is only intended for information purposes. This presentation was made by Itamar Medical LTD (“The Company”). The information in the presentation and any other data that will be provided during the presentation (“The Information”) is not a basis for investment decision, and does not constitute a recommendation or opinion, and also it is not a substitute for the judgment of the potential investor. The mentioned in the presentation regarding the analysis of activity of the company is a summery only, and in order to get a complete picture of the company’s activity and of the risks the company copes with, please refer to the full statements of the company with the securities and stock exchanges. The company is not responsible for the completeness or accuracy of the information. And will not be liable for any damages and/or losses that may be caused from the use of the information. The presentation may include a forward looking statements as defined in securities law, 1968. This information includes forecasts and/or based estimations, among others on data available to the company as of this date, the company’s internal evaluations, and expectations. The company has no assurance that it’s forecasts and/or estimations will be realized, in whole or in part or will be realized in a different way, and this is partly due to other factors beyond the company’s control, including: changes in the condition of market and the competitive or business surroundings, regulatory changes, changes in the production costs, changes in the raw material prices, changes in supply and demand, financing methods, or occurrences of any of the company’s risk factors. Also forecasts and forward looking estimations that are based on data and information that are held by the company at the time of preparation of the presentation and the company does not oblige to update and/or change forecast and/or estimate to reflect events and/or circumstances which will occur after the date of preparation of this presentation. The company does not oblige to perform actual issuing of the securities of the company, and performing actual issue is subjected to the company’s judgment.

3 Mission Vision Improving Health Through the PAT™ Signal Making the PAT™ Signal Standard of Care

4 The Scientific Foundations- Endothelial Function Research Evolution Development of Arterial Function Study Furchgott, Ignarro & Murad discover Nitric-Oxide’s role in CV regulation. Nobel Prize awarded in 1998 Ganz’s group assess intra-coronary endothelial function Celermajer & Deanfield describe technique of ultrasonic assessment of Flow Mediated Dilation Lerman’s group validate Endo-PAT2000 with intra-coronary AcetylCholine

5 The Technology Unique and innovative technology: PAT ® - Peripheral Arterial Tone Enables detecting the functioning and health of the arteries by PAT® Main uses (today) – diagnosis of heart disease and sleep apnea + ALGORYTHMS WatchPAT™ EndoPAT™

6 USA The largest medical device market Ageing population USA The largest medical device market Ageing population ISRAEL Center of Excellence ISRAEL Center of Excellence JAPAN Ageing population Advanced medicine Endothelial function awareness JAPAN Ageing population Advanced medicine Endothelial function awareness Strategic Focus – by Geographic Regions

7 Organizing & Leveraging Existing Business The Road Ahead

8 Turn Sales force to Call On Clinical Accounts Turn Sales force to Call On Clinical Accounts Salesforce expansion Organic and channels Salesforce expansion Organic and channels Focus on NYC Financing & Rent options Reimbursement Focus on the US Leadership

9 Organizing & Leveraging Existing Business The Road Ahead Grow WatchPAT™ Market and Channels

10 Sleep Market in the USA 2010 vs. 2016 *-Source: BCC Research; www.bccresearch.com/report/HLC081A.html company assessment, and empirical analysiswww.bccresearch.com/report/HLC081A.html based upon deployment in Israel www.ibisworld.com/industry/sleep-disorder-clinics.htmlwww.ibisworld.com/industry/sleep-disorder-clinics.html

11 Drug Resistance Hypertension Obesity Congestive Heart Failure Type 2 Diabetes Stroke Pacemakers Acute Coronary Syndrome Atrial Fibrillation Depression US Sleep Apnea Market – Co-Morbidities Source: ResMed investor presentation Q3 2013

12 Clinical Studies– OSA and AF Treatment of obstructive sleep apnea reduces the risk of atrial fibrillation recurrence after catheter ablation (Fein et al, JACC July 2013)Fein et al Dr. Mark Josephson Beth Israel #pts 30 32 30 22 Total 426 patients who underwent initial PVI – of whom 62 diagnosed with OSA Managing Sleep Apnea May Lower the Risk of Atrial Fibrillation (AF) Recurrence after Catheter Ablation.

13 The Sleep Market Does Not Meet the Needs of Cardiology Patients Few Dominant Providers Limited Number of Sleep Docs Un-served Cardiology Market 220k Ablations is 2014 ~3M Patients with A.Fib

14 Serving an Unmet Need

15 Itamar’s Plan to Serve the Cardiology Market A.Fib OEM ~1200 Reps HST + IT Solution Few Dominant Providers Limited Number of Sleep Docs 220k Ablation is 2014 3M Patients with A.Fib Home service providers for OSA treatment e.g. VGM

16 95% of sleep studies performed at the lab Because HST has not been accepted by authorities as an accurate sleep-stages diagnostic tool or considered too cumbersome The Japanese Sleep Market

17 Organizing & Leveraging Existing Business The Road Ahead Grow WatchPAT™ Market And Channels EndoPAT™ Adding the Ripe Secondary Prevention segment

18 מקורGo A S et al. Circulation 2013;127:e6-e245 US: Direct and Indirect Costs of Cardiovascular Disease $ billions in 2010 Source: Go A S et al. Circulation 2013;127:e6-e245

19 Time to Market Care continuum 5-10 years now Post-diagnosisPrevention 1-2 years US Potential Market Segments Primary prevention Framingham Risk Index Enhancement 217m pts Targeting all Physicians (115,000) Unique and promising Large market which will mature in 3-5 years “Be as important as the cholesterol test today”

20 Time to Market Care continuum 5-10 years now Post-diagnosisPrevention 1-2 years LONG-TERM OUTCOME STUDIES *5609 subjects since 2003 ** 1877 subjects since 2007 *** 13,744 subjects since 2007 US Potential Market Segments Ongoing studies FRAMINGHAM STUDY * JACKSON Heart study** Prevent IT Guttenberg Heart study*** KORA (Augsburg Primary prevention Framingham Risk Index Enhancement 217m

21 Time to Market Care continuum 5-10 years now Post-diagnosisPrevention 1-2 years US Potential Market Segments* “Be as important as the cholesterol test today” “People who are health conscious” Existing and mature professional market Primary Prevention Framingham Risk Index Enhancement 217m Wellness and Early Detection 76m Diagnosis of Sleep Apnea 58m Secondary Prevention & monitoring post Cardiac Event 16m Targeting Cardiologist (22,000) “Symptomatic heart patients or post cardiac event patients”

22 Time to Market Care continuum 5-10 years now Post-diagnosisPrevention 1-2 years * USA Markets Only US: Adding the Cardiology Market in the Short Term CPT codes old– 93922 / 93923 0337T (Cat III)- as of Jan 1 st 2014 INSURANCE COVERAGE Primary prevention Framingham Risk Index Enhancement 217m Wellness and Early detection 76m Completed published studies KITTA RUBINSTEIN MODENA Matsuzawa X2 Matsue Secondary Prevention & monitoring post Cardiac Event 16m Targeting Cardiologist (22,000) Diagnosis of sleep apnea 58m

23 Major Clinical Studies Related to the Cardiology Market

24 Post-PCI Patients Current market segment: using the EndoPAT™ to identify near-future cardiac risk METHOD: 528 patients with chest pain or high risk of cardiac disease were sent to angiography and tested with the EndoPAT™. The rate of cardiac events was almost 4 times higher in the group of endothelial dysfunction: (32%) vs. 8% in the normal function group. 2.6M** Angiographies performed in the USA In 2010 Peripheral dysfunction of the endothelium found to be independent predictor of cardiac events in the near future, adding a clinical classification of patients at high risk of 49% over than FRS or any other tests used. *Peripheral endothelial function and cardiovascular events in high-risk patients, Matsazawa et al, J Am Heart Assoc. 2013 **US Markets for Interventional Cardiology Devices 2013, Millenium Research Group, 2012 Patients were followed up for a mean of 3 years Market segment in the near future: EndoPAT™ can be used to follow up on patients after angiography to identify, monitor and treat more aggressively patients at risk for near-future events Patient PopulationUnique EndoPAT™ Value Study Outcome

25 Symptomatic Patients with Chest Pain Current market segment: using EndoPAT™ in cardiac patients where standard tests fail to diagnose 8.9M Patients Showing up at Doctor’s Offices Every Year with Stable Angina Pectoris Patient Population Study Outcomes * “Assessment of endothelial function by non-invasive PAT predicts late cardiovascular adverse events” Rubinstein et al European Heart Journal (2010)31, 1142–1148 EndoPAT™ Unique Value Market segment in the near future: using EndoPAT ™ for all cardiac patients, since the test is affordable and easily performed at the cardiologist office

26 Post Heart Attack Patients Current market segment: using EndoPAT™ in all CAD patients that are on statin therapy METHOD: 213 CAD patients who achieved LDL<100 by statin therapy : During follow-up, CAE occurred in 6 (4%) patients in the L_RHI ≥0.54 group and 16 (15.8%) patients in the L_RHI <0.54 group (P=0.023). Patients were followed-up for secondary CAE for a median of 2.7 years 7.6M** Post AMI Patients Under cardiologist follow- up Patient PopulationUnique EndoPAT™ Value L_RHI (Endoscore) was an independent predictor for CAE (coronary artery events) even after adjusting by Framingham traditional risk factors for secondary CAE Study Outcomes Market segment in the near future: using EndoPAT ™ to follow up on CAD patients to improve the prognosis (survival chances) *Endothelial dysfunction predicts residual risk in coronary artery disease patients with Statin therapy, Matsue et al abs, Atherosclerosis 2014, AHA statistics

27 METHOD: 321 patients with heart failure tested with EndoPAT. Rate of adverse events was almost 4 times in the group of endothelial dysfunction (28.1%) vs. 8.8% in the normal function group 5.1M** diagnosed heart failure patients (2007-2010) Peripheral endothelial dysfunction independently correlated with future cardiovascular events, adding incremental clinical significance for risk stratification in patients with HF. * Akiyama, JACC, Journal of American College of Cardiology, 2012 ** AHA heart disease and stroke statistics 2013 update, Circulation 2013 Heart Failure Patients Current market segment: using the EndoPAT™ to identify high-risk HF patients Patient PopulationUnique EndoPAT™ ValueStudy Outcomes Market segment in the near future: using the EndoPAT™ to follow up all HF patients, when the goal is to prevent readmissions and improve the prognosis (survival chances)

28 The EndoPAT® is Used by US Leading Cardiologists

29 Supporting Mega Trends

30 The Healthcare Reform for Better Value Health Care The program for readmissions reduction * Source: Agency for Healthcare Research and Quality WSJ article “Don’t come back. Hospitals say”WSJ article The Program focus % Medicare Patients Readmitted to Hospitals in 2010 within 30-days

31 The Affordable Care Act’s Proposed 2-Midnight rule Two – Midnight rule (CMS): reducing hospital admission and transition to outpatient clinics Reducing admissions- hospitals will only be paid inpatient fees if a patient requires treatment of at least two days of hospital stay. A Patient stay of less than two days will be handled as an outpatient treatment, for which the hospitals get lower coverage Problematic with patients that require prolonged stay for follow-up to avoid readmissions. Might dramatically cut payments to hospitals for angiographies, which will not be considered inpatient procedure Raises hospitals’ incentive to offer tests or medical services that can be provided by outpatient clinics to compensate for loss of revenue

32 Focus, Focus and Focus

33 Thank You!

34 EndoPAT: the Only Technology for Clinical Practice (192 references) EndoPAT™: the Only Technology for Clinical Practice (192 references) CLINICAL IMPLICATIONS Extensive literature documents that endothelial dysfunction is associated with almost every condition predisposing to atherosclerosis and cardiovascular disease.

35 Sleep Disorder Diagnostics How is a sleep disorder diagnosed? Do you prefer a lab test … or at home? PSG WatchPAT™


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