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Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014.

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Presentation on theme: "Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014."— Presentation transcript:

1 Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

2 Disclaimer Development of Arterial Function Study Itamar Medical Ltd. (the "Company") is furnishing this presentation and any information given during this presentation, solely for the consideration of eligible investors who have the knowledge and experience in financial and business matters and the capability to conduct their own due diligence investigation in connection with the investment outlined herein. Prospective investors are urged to conduct an independent evaluation of the Company. This presentation does not constitute an offer of securities of the Company, or a solicitation to acquire or sell the Company’s securities or to participate in any investment in the Company. The statements in this presentation should not be regarded as a basis for an investment decision of any kind, or as recommendation or opinion, or a substitute for investor discretion. Statements in this presentation that are not historical facts might be considered as forward-looking statements based on current expectations of future events, in accordance with the Israeli Securities law, (the “Securities Law”). These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements as a result of different factors including, but not limited to, the market demands for the Company's products; changes in general economic and business conditions; inability to maintain market acceptance of the Company's products; inability to timely develop and introduce new technologies and products; rapid changes in the market for the Company's products; loss of market share and pressure on prices resulting from competition; introduction of competing products by other companies; inability to manage growth and expansion; inability to attract and retain qualified personnel; and inability to protect the Company's proprietary technology. All forward-looking statements included in this presentation are made only as of the date of this presentation. We assume no obligation to update any written or oral forward-looking statement made by us or on our behalf as a result of new information, future events or other factors. The United States and Israeli securities laws prohibit any person who has material non-public information about a company ("Inside Information"), from purchasing or selling securities of such company, or from communicating such information to any other person under circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities. Statements in this presentation and in any information given during this presentation might be considered as Inside Information, in accordance with the Securities Law. Therefore, any person aware of this presentation or of any information given during this presentation, may neither use, nor cause any third party to use, any Inside Information or any other information provided in connection with the presentation, in contravention of the Securities Law or any such rules and regulations thereunder. The Company, and its respective affiliates, employees and representatives expressly disclaim any and all liability relating to or resulting from the use of this presentation or any information given during this presentation or such other information by a prospective investor or any of its affiliates or representatives.

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

4 Investment Highlights Development of Arterial Function Study Patented platform PAT® technology – Accurate assessment of multiple disease states Non Invasive Easy to use More than a Decade: Pioneering of Science and Technology – > 400 Published peer-reviewed outcome studies in multiple disease states now ripe for commercialization Commercialized proprietary product lines in 2 major growth markets CE, MHLW, FDA-cleared Sleep apnea and cardiovascular disease Reimbursement in most major markets in the world Growth drivers Favorable healthcare trends and economics for both products Newly published outcome studies Channel development under way Philips Japan – exclusive WatchPAT™ distribution Medtronic US – exclusive electrophysiology WatchPAT™ co-marketing agreement Experienced management team and board and a solid shareholder base

5 Patented platform PAT® technology – Accurate assessment of multiple disease states Non Invasive Easy to use More than a Decade: Pioneering the Science and Technology > 400 Published peer-reviewed outcome studies in multiple disease states Framingham heart study, Prevent IT Guttenberg Heart study, KORA now ripe for commercialization Commercialized proprietary product lines in 2 major growth markets CE, MHLW, FDA-cleared Sleep apnea and cardiovascular disease Reimbursement in most major markets in the world Growth drivers Favorable healthcare trends and economics for both products Newly published outcome studies Channel development under way Philips Japan – exclusive WatchPAT™ distribution Medtronic US – exclusive electrophysiology WatchPAT™ co-marketing agreement Experienced management team and board and a solid shareholder base Investment Highlights Development of Arterial Function Study

6 Facts and Figures Development of Arterial Function Study Publicly traded since 2007 (TASE:ITMR) 2 Product lines 1.WatchPAT™ - home diagnostic device for sleep disorders 2.EndoPAT™ - the only functional marker proven to predict cardiovascular risk beyond commonly used risk scores Business indices – > 650,000 patients diagnosed – > 5,500 WatchPAT™ sold – > 1,500 EndoPAT™ sold Financial indices – Gross profit >70% – 2013 Sales: $13.5MM – Market Cap: ~$120M – Currently ~50% sales from disposables Broad scientific base – 370 peer-reviewed publications, 490 abstracts Broad IP coverage – 72 patents issued, 25 pending Reimbursement Dedicated CPT codes: – WatchPAT™ – EndoPAT™ 0337T Major distribution deals – Philips Japan – Medtronic US – Thorne

7 Facts and Figures Development of Arterial Function Study Publicly traded since 2007 (TASE:ITMR) 2 Product lines 1.WatchPAT™ - home diagnostic device for sleep disorders 2.EndoPAT™ - the only functional marker proven to predict cardiovascular risk beyond commonly used risk scores Broad scientific base – 370 peer-reviewed publications, 490 abstracts Broad IP coverage – 72 patents issued, 25 pending Reimbursement Dedicated CPT codes: – WatchPAT™ – EndoPAT™ 0337T Business indices – > 650,000 patients diagnosed – > 7,000 machines sold Financial indices – Gross profit >70% – 2013 Sales: $13.5MM – Market Cap: ~$120M – Razor-Razor blade model Currently ~50% sales from disposables – Major Shareholder – Medtronic (22%) Major distribution deals / Customers – Philips Japan – Medtronic US – Thorne – Kaiser Permanente – VA (Veterans Affairs)

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

9 The Technology Innovative proprietary technology: PAT ® - Peripheral Arterial Tone – a unique signal Combination of pulse pneumatic and optical sensors Detecting changes in and responses of the sympathetic autonomic nervous system ALGORYTHMS Sleep Heart WatchPAT™ EndoPAT™ Need to add a picture of the device in a test environment (Pts+device) – to be in same format as the watchPAT

10 IP Portfolio Expiration of Initial PAT patents: 2017 Expiration of major extension patents: 2022 Provisional extensions: >2030 Product- specific Umbrella Patents PAT® WatchPAT™EndoPAT™ WatchPAT™ and EndoPAT™ are both protected by a robust IP portfolio protecting all aspects of the proprietary platform

11 Experienced Leadership and Advisory Team Gilad Glick Chief Executive Officer Shaul Sharoni Chief Financial Officer Eldad Singer Vice President, International Sales Dr. Koby Sheffy SVP & Chief Technology Officer Efrat Litman VP, Research & Development Shlomo Ayanot VP Engineering & Operations Martin GerstelProf. Amir Lerman Assoc. Chair Cardiovascular Division for Academic Affairs, Mayo Clinic Gary Ellis SVP & CFO, Medtronic Dr. Giora Yaron Dr. Morry Blumenfeld Past Managing Director Regina Ungar CPA Miri Katz Past Chairman of Israeli Securities Authority Ilan Biran Prof. Peter Ganz Chief Division of Cardiology, UCSF, SF General Hospital Prof. Mark Creager Director Vascular Center, Brigham & Women’s Hospital, Harvard Medical. Prof. Michael Shechter Director Clinical Research Unit, Heart Center, Sheba Medical Center, Tel Aviv Dr. Steven Lamm, Internal Medicine; Faculty NYU School of Medicine Prof. Peter Collins, Chief Cardiol. Imperial College & Brompton Hospital Prof. Giora Pillar Head of pediatrics Department, Carmel Hospital, and sleep laboratory at Rambam Medical Center Maya Tal Director, Global Marketing Chris Hallett VP US Sales ManagementBoard of DirectorsScientific Advisory Board Have added compugen logo

12 EndoPAT®

13 The EndoPAT® Quiet Revolution

14 The only non-invasive, FDA-cleared device assessing endothelial dysfunction– functional test of arterial health  15 minute  Non-invasive  Office-based diagnostic test  350,000+ tests to date  Can be performed by an AHP  Reimbursed Animation The EndoPAT® Test

15 The only non-invasive, FDA-cleared device assessing endothelial dysfunction– functional test of arterial health  15 minute  Non-invasive  Office-based diagnostic test  350,000+ tests to date  Can be performed by an AHP  Reimbursed Animation The EndoPAT® Test

16 Prevalence in the US ( Million Patients) Good Bad 8% 32% 4% 15.8% 28% 48% 8.8% 28.1% Matsazawa et al 2013 Matsue et al, 2014 Rubinstein et al, 2010 Akiyama et al, pts 213 pts 270 pts 320 pts Adverse Cardiac Events PAT Score Published Outcome Evidence

17 Current Environment Positions EndoPAT™ for Success Outcome studies

18 Prevalence* in the US ( Million Patients) Good Bad 8% 32% 4% 15.8% 28% 48% 8.8% 28.1% Matsazawa et al 2013 Matsue et al, 2014 Rubinstein et al, 2010 Akiyama et al, pts 213 pts 270 pts 320 pts Adverse Cardiac Events EndoPAT Score * Not mutually exclusive Need to add duration of the Study Need to adjust format – spaces, missing “,” Need to add yesterday paper Published Outcome Evidence

19 Current Environment Positions EndoPAT™ for Success Outcome studiesCPT code Jan 2014 Affordable care act readmissions focus CMS 2-midnight rule Personalized medicine Cardiac technology maturing

20 Current Environment Positions EndoPAT™ for Success Outcome studiesCPT code Jan 2014 Affordable care act readmissions focus CMS 2-midnight rule Personalized medicine Cardiac technology maturing Need to add: Readmission = loss of revenues/reimbursement

21 Strategy Implementation is Underway

22 The 3 Horizons for Growth Readmission Mng Symptomatic & CAD patients Primary prevention “Blood-pressure” like test Horizon 1 Core market Growth Primary care Horizon 2 Cardiology Acute care Horizon 3 Cardiology Primary care * * US patient population based on AHA statistics

23 23 Cleveland Clinic Top 10 Medical Innovation for 2010 WatchPAT™ Taking on The Underserved Cardiology Market

24 Obstructive Sleep Apnea (OSA) Sleep Apnea causes serious illnesses directly increasing medical costs Confidential 40 million Americans undiagnosed with OSA* Costly personal health issues Adverse OSA outcomes  High blood pressure  Vascular disease and mortality  Arrhythmias  Metabolic syndrome and diabetes  Sexual dysfunction  Cognitive impairment & accidents * Source: American Academy of Sleep Medicine

25 Sleep Disorder Diagnosis The Old Polysomnography Way The New WatchPAT® Way

26 Obstructive Sleep Apnea Product Landscape Confidential In-lab PSG tests Unattended PSG tests Embla, Aura-Grass, Braebon Home Sleep tests Embletta, ARES, Stardust, ApneaLink+, Nox Pulse Oximetry Nonin, Masimo Simplicity Clinical information >6 parameters 4-5 parameters 1-2 parameters WatchPAT: best in breed for Home Sleep Testing – easy & informative itamar Unique: w/CloudPAT & Bracelet Kaiser/ VA

27 The Traditional Sleep Market – USA 2010 vs *-Source: BCC Research; company assessment, and empirical analysiswww.bccresearch.com/report/HLC081A.html based upon deployment in Israel Sleep Market Structure 2012 Need to emphasis Cardiology We see positive momentum/ movement to HST but have decided to leverage our strength and relationship in Cardiology. Going to be Premier Company in cardiology space

28 Itamar’s Potential Market Beyond The Traditional Sleep Market Source: Epidemiological studies, Market reports Sleep Apnea Prevalence 83% 86% 49% 59% Device market ($ Bn) Check Prevalence % Need to correct miss-spelling

29 OSA prevalence in AF patients 1 OSA Prevalence in the general population 2 49% 9-24 % How are you currently managing your potential AF ablation candidates that might have OSA? Anesthesiology Practice Guidelines state that for patients with clinical signs and symptoms suggesting the possibility of OSA, a sleep study is encouraged prior to surgery 3 OSA occurs when the muscles in the back of the throat fail to keep the airway open and resulting in brief and repeated breathing interruption during sleep Obstructive Sleep Apnea - Common Comorbidity of AF

30 Treatment of Obstructive Sleep Apnea Reduced the Risk of Atrial Fibrillation Recurrence After Catheter Ablation (Fein, Josephson et al. JACC July 2013 ) The authors concluded that “CPAP is an important therapy in OSA patients undergoing PVI that improves arrhythmia free survival. PVI offers limited value to OSA patients not treated with CPAP.” Subjects: Retrospective review of 426 PVI patients, of which 62 patients with OSA Method: During a follow-up period of 12 months after PVI, CPAP therapy resulted in higher AF-free survival rate (71.9% vs. 36.7%; p = 0.01). PVI + no OSA PVI + CPAP treated OSA No PVI + CPAP treated OSA PVI + untreated OSA Evidence and Literature – OSA and AF

31

32 The Japanese Sleep Market In a market without sleep docs – Philips chose WatchPAT™ as their flagship product Sleep specialist Cardiologist GP ENTs GP SLEEP study THERAPY Cardiologist SLEEP study THERAPY ENT SLEEP study THERAPY Therapy

33 Horizon 1 Core market Growth Horizon 2 Cardiology Horizon 3 Beyond Cardiology Traditional Sleep market New studies demonstrating WP is significantly more sensitive Philips Japan MDT Afib US ‒CRT space Diabetes Obesity The 3 Horizons for Growth

34 USA Israel Japan The largest medical device market Ageing population The largest medical device market Ageing population Center of Excellence Center of Excellence Ageing population Advanced medicine Endothelial function awareness Ageing population Advanced medicine Endothelial function awareness Strategic Focus – by Geographic Regions

35 Patented platform PAT® technology 2 Commercialized proprietary product lines in major growth markets CE, MHLW, FDA-cleared sleep apnea and cardiovascular disease Published peer-reviewed outcome studies in multiple disease states Reimbursement in most major markets in the world Growth drivers Philips Japan – exclusive WatchPAT™ distribution Medtronic US – exclusive electrophysiology WatchPAT™ co-marketing agreement Favorable healthcare trends and economics for both products Newly published outcome studies Experienced management team and board and a solid shareholder base Investment Highlights Development of Arterial Function Study

36 Investment Highlights Development of Arterial Function Study Patented platform PAT® technology – Accurate assessment of multiple disease states Non Invasive Easy to use More than a Decade: Pioneering the Science and Technology > 400 Published peer-reviewed outcome studies in multiple disease states Framingham heart study, Prevent IT Guttenberg Heart study, KORA now ripe for commercialization Commercialized proprietary product lines in 2 major growth markets CE, MHLW, FDA-cleared Sleep apnea and cardiovascular disease Reimbursement in most major markets in the world Growth drivers Favorable healthcare trends and economics for both products Newly published outcome studies Channel development under way Philips Japan – exclusive WatchPAT™ distribution Medtronic US – exclusive electrophysiology WatchPAT™ co-marketing agreement Experienced management team and board and a solid shareholder base

37 Financials

38

39 Business Model Shaul to add tonight

40 Thank you!

41 41 Sales, $, Million Acquired SteriOss Market cap : 1.3x Revenue Market cap : 13x Revenue Nobel Biocare tried to do directly to general dentists – and never recovered Incumbents are Penalized for Bypassing Specialists

42 Value-Based Payment Methods of the Federal Government - CMS As part of the health reform - Affordable Care Act Hospitals will be compared to the average so either they continue improving or they will get less funding * Source: Value based purchasing at a glance, Studer group, CMS

43 The Problem: cardiology-related readmissions Post-stenting Unexplained chest pain Heart failure * Source: American Heart Association, 2010 * Source: Agency for Healthcare Research and Quality WSJ article “Don’t come back. Hospitals say”WSJ article Itamar’s strength % Medicare Patients Readmitted to Hospitals in 2010 within 30-days

44 Source: ResMed investor presentation Q Itamar’s Potential Market Beyond the Traditional Sleep Market


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