Presentation Transcript

1. Itamar Medical Ltd Investor Presentation January 2014
2. Disclaimer 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. (c) Itamar-Medical
3. Mission Improving Health Through the PAT™ Signal Vision 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 validateEndo-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 WatchPAT™ + ALGORYTHMS Sleep Heart EndoPAT™
6. Strategic Focus – by Geographic Regions JAPAN Ageing population Advanced medicine Endothelial function awareness USA The largest medical device market Ageing population ISRAEL Center of Excellence
7. The Road Ahead Organizing & Leveraging Existing Business
8. Focus on the US Reimbursement Turn Sales force to Call On Clinical Accounts Leadership Salesforce expansion Organic and channels Focus on NYC Financing & Rent options
9. The Road Ahead Grow WatchPAT™ Market and Channels Organizing & Leveraging Existing Business
10. Sleep Market in the USA 2010 vs. 2016 *-Source: BCC Research; www.bccresearch.com/report/HLC081A.htmlcompany assessment, and empirical analysis based upon deployment in Israelwww.ibisworld.com/industry/sleep-disorder-clinics.html
11. US Sleep Apnea Market – Co-Morbidities Drug Resistance Hypertension Obesity Congestive Heart Failure Type 2 Diabetes Stroke Pacemakers Acute Coronary Syndrome Atrial Fibrillation Depression 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) #pts 30 32 30 22 Total 426 patients who underwent initial PVI – of whom 62 diagnosed with OSA Dr. Mark Josephson Beth Israel 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 3000 Un-served Cardiology Market Evidence 220k Ablations is 2014 ~3M Patients with A.Fib
14. Serving an Unmet Need
15. Itamar’s Plan to Serve the Cardiology Market Few Dominant Providers Limited Number of Sleep Docs Home service providers for OSA treatment e.g. VGM A.Fib OEM ~1200 Reps Evidence HST + IT Solution 220k Ablation is 2014 3M Patients with A.Fib
16. The Japanese Sleep Market 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
17. The Road Ahead EndoPAT™ Adding the Ripe Secondary Prevention segment Grow WatchPAT™ Market And Channels Organizing & Leveraging Existing Business
18. US: Direct and Indirect Costs of Cardiovascular Disease $ billions in 2010 Source: Go A S et al. Circulation 2013;127:e6-e245 מקורGo A S et al. Circulation 2013;127:e6-e245
19. US Potential Market Segments Time to Market Unique and promising Large market which will mature in 3-5 years 5-10 years Primary preventionFramingham Risk IndexEnhancement217m ptsTargeting all Physicians(115,000) “Be as important as the cholesterol test today” 1-2 years now Care continuum Post-diagnosis Prevention
20. US Potential Market Segments Time to Market LONG-TERM OUTCOME STUDIES 5-10 years Primary preventionFramingham Risk IndexEnhancement217m Ongoing studies FRAMINGHAM STUDY * JACKSON Heart study** Prevent IT Guttenberg Heart study*** KORA (Augsburg 1-2 years now Care continuum Post-diagnosis Prevention *5609 subjects since 2003 ** 1877 subjects since 2007 *** 13,744 subjects since 2007
21. US Potential Market Segments* Time to Market Existing and mature professional market 5-10 years Primary PreventionFramingham Risk IndexEnhancement217m “Symptomatic heart patients or post cardiac event patients” Secondary Prevention & monitoring post Cardiac Event16mTargeting Cardiologist(22,000) “Be as important as the cholesterol test today” Wellness and Early Detection76m 1-2 years Diagnosis of Sleep Apnea 58m “People who are health conscious” now Care continuum Post-diagnosis Prevention
22. US: Adding the Cardiology Market in the Short Term Time to Market INSURANCE COVERAGE CPT codes old– 93922 / 93923 0337T (Cat III)- as of Jan 1st 2014 5-10 years Primary preventionFramingham Risk IndexEnhancement217m Secondary Prevention & monitoring post Cardiac Event16mTargeting Cardiologist(22,000) Wellness and Early detection76m 1-2 years Diagnosis of sleep apnea 58m Completed published studies KITTA RUBINSTEIN MODENA Matsuzawa X2 Matsue now Care continuum Post-diagnosis Prevention * USA Markets Only
23. Major Clinical StudiesRelated to the Cardiology Market
24. Post-PCI Patients Current market segment: using the EndoPAT™ to identify near-future cardiac risk Patient Population Unique EndoPAT™ Value Study Outcome 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 riskof 49% over than FRS or any other tests used . 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 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 *Peripheral endothelial function and cardiovascular events in high-risk patients, Matsazawaet al , J Am Heart Assoc. 2013 **US Markets for Interventional Cardiology Devices 2013, Millenium Research Group, 2012
25. Symptomatic Patients with Chest Pain Current market segment: using EndoPAT™ in cardiac patients where standard tests fail to diagnose Patient Population EndoPAT™ Unique Value Study Outcomes 8.9M Patients Showing up at Doctor’s Offices Every Year with Stable Angina Pectoris Market segment in the near future: using EndoPAT ™ for all cardiac patients, since the test is affordable and easily performed at the cardiologist office * “Assessment of endothelial function by non-invasive PAT predicts late cardiovascular adverse events” Rubinstein et al European Heart Journal (2010)31, 1142–1148
26. Post Heart Attack Patients Current market segment: using EndoPAT™ in all CAD patients that are on statin therapy Patient Population Study Outcomes Unique EndoPAT™ Value 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 L_RHI (Endoscore) was an independent predictor for CAE (coronary artery events) even after adjusting by Framingham traditional risk factors for secondary CAE 7.6M** Post AMI Patients Under cardiologist follow- up Market segment in the near future: usingEndoPAT ™ 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. Heart Failure Patients Current market segment: using the EndoPAT™ to identify high-risk HF patients Patient Population Study Outcomes Unique EndoPAT™ Value 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 Peripheral endothelial dysfunction independently correlated with future cardiovascular events, adding incremental clinical significance for risk stratification in patients with HF. 5.1M** diagnosed heart failure patients (2007-2010) 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) * Akiyama, JACC, Journal of American College of Cardiology, 2012 ** AHA heart disease and stroke statistics 2013 update, Circulation 2013
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 % Medicare Patients Readmitted to Hospitals in 2010 within 30-days The Program focus * Source: Agency for Healthcare Research and Quality WSJ article “Don’t come back. Hospitals say”
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) CLINICAL IMPLICATIONS Extensive literature documents that endothelial dysfunction is associated with almost every condition predisposing to atherosclerosis and cardiovascular disease.
35. How is a sleep disorder diagnosed? Do you prefer a lab test … or at home? PSG WatchPAT™