itamar medical ltd. transferring great science into patient care april 2014

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

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

Itamar Medical Ltd. Transferring Great Science into Patient Care

April 2014

Page 2: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Disclaimer Development of Arterial Function StudyItamar 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, 5728-1968 (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.

Page 3: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Making the PAT® Signal Standard of Care

Mission

Vision

Improving Health Through the PAT® Signal

Page 4: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Investment HighlightsDevelopment 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

Page 5: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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 HighlightsDevelopment of Arterial Function Study

Page 6: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Facts and FiguresDevelopment of Arterial Function Study• Publicly traded since 2007 (TASE:ITMR)

• 2 Product lines1. 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

• ReimbursementDedicated CPT codes:– WatchPAT™ - 95800– EndoPAT™ 0337T

• Major distribution deals– Philips Japan– Medtronic US– Thorne

Page 7: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Facts and FiguresDevelopment of Arterial Function Study• Publicly traded since 2007 (TASE:ITMR)

• 2 Product lines1. 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™ - 95800– 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)

Page 8: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

The Scientific Foundations Development of Arterial Function Study

Ganz’s group assessintra-coronary endothelial

function

Lerman’s group validateEndo-PAT2000 with

intra-coronary AcetylCholine

Furchgott, Ignarro & Muraddiscover Nitric-Oxide’s role

in CV regulation.Nobel Prize awarded in 1998

Celermajer & Deanfielddescribe technique of ultrasonic

assessment of Flow Mediated Dilation

1980 1986 1992 2004

Page 9: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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

ALGO

RYTHM

S

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

Page 10: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

IP Portfolio

Expiration of Initial PAT patents: 2017Expiration 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

Page 11: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Experienced Leadership and Advisory TeamGilad GlickChief Executive Officer

Shaul SharoniChief Financial Officer

Eldad Singer Vice President, International Sales

Dr. Koby SheffySVP & Chief Technology Officer

Efrat LitmanVP, Research & Development

Shlomo AyanotVP Engineering & Operations

Martin Gerstel Prof. Amir LermanAssoc. Chair Cardiovascular Division for Academic Affairs , Mayo Clinic

Gary EllisSVP & CFO, Medtronic

Dr. Giora Yaron

Dr. Morry BlumenfeldPast Managing Director

Regina UngarCPA

Miri KatzPast Chairman of Israeli Securities Authority

Ilan Biran

Prof. Peter GanzChief Division of Cardiology, UCSF, SF General Hospital

Prof. Mark CreagerDirector Vascular Center, Brigham & Women’s Hospital, Harvard Medical.

Prof. Michael ShechterDirector 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 PillarHead of pediatrics Department, Carmel Hospital, and sleep laboratory at Rambam Medical Center

Maya TalDirector, Global Marketing

Chris Hallett VP US Sales

Management Board of Directors Scientific Advisory Board

Have added compugen logo

Page 12: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

EndoPAT®

Page 13: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

The EndoPAT® Quiet Revolution

Page 14: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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

Page 15: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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

Page 16: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Post stenting

CAD patients

Chest pain

Heart failure

7.8

16

8.9

5.1

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, 2012

528 pts

213 pts

270 pts

320 pts

Adverse Cardiac Events

PAT ScorePublished Outcome Evidence

Page 17: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Current Environment Positions EndoPAT™ for Success

Outcome studies

Page 18: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Post stenting

CAD patients

Chest pain

Heart failure

7.8

16

8.9

5.1

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, 2012

528 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 yeste

rday paper

Published Outcome Evidence

Page 19: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Current Environment Positions EndoPAT™ for Success

Outcome studies CPT code Jan 2014 Affordable care act readmissions

focus

CMS 2-midnight rule

Personalized medicine

Cardiac technology maturing

Page 20: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Current Environment Positions EndoPAT™ for Success

Outcome studies CPT 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

Page 21: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Strategy Implementation is Underway

Page 22: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

The 3 Horizons for Growth

Readmission MngSymptomatic & CAD

patients

Primary prevention“Blood-pressure” like test

Horizon 1Core market

GrowthPrimary care

Horizon 2CardiologyAcute care

Horizon 3CardiologyPrimary care

*

* US patient population based on AHA statistics

Page 23: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

23

Cleveland ClinicTop 10 Medical

Innovation fo

r 2010WatchPAT™

Taking on The Underserved Cardiology Market

Page 24: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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

Page 25: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Sleep Disorder Diagnosis

The Old Polysomnography Way The New WatchPAT® Way

Page 26: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Obstructive Sleep Apnea Product Landscape

Confidential

In-lab PSG tests

Unattended PSG testsEmbla, Aura-Grass, Braebon

Home Sleep testsEmbletta, ARES, Stardust,

ApneaLink+, Nox

Pulse OximetryNonin, Masimo

Simplicity

Clin

ical

info

rmati

on

>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

Page 27: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

The Traditional Sleep Market – USA2010 vs. 2016

27

*-Source: BCC Research; www.bccresearch.com/report/HLC081A.html company assessment, and empirical analysis based upon deployment in Israel www.ibisworld.com/industry/sleep-disorder-clinics.html

ResMed40%

Philips43%

FP10%

other7%

Sleep Market Structure2012

20102013

20160

1

2

3

4

5

6

7

Home test

Home test

Home test

Lab

Lab

Lab

Number of Sleep Tests Performed in M

Need to emphasis CardiologyWe 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

Page 28: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Itamar’s Potential Market Beyond The Traditional Sleep Market

Source: Epidemiological studies, Market reports

Drug resistant hypertension

Congestive Heart Failure - CRT

Aririal Fibrillation

Pacemakers

0.2

2.1

2.6

3

Sleep Apnea Prevalence

83%

86%

49%

59%

Device market ($ Bn)

Check Prevalence %

Need to correct miss-spelling

Page 29: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

OSA prevalence in AF patients1

OSA Prevalence in the general population2

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 surgery3

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

Page 30: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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 OSAPVI + CPAP treated OSANo PVI + CPAP treated OSAPVI + untreated OSA

Evidence and Literature – OSA and AF

Page 31: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014
Page 32: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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

Page 33: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Horizon 1Core market

Growth

Horizon 2Cardiology

Horizon 3Beyond

Cardiology

Traditional Sleep marketNew studies demonstrating WP is significantly more sensitive

Philips Japan MDT Afib US‒ CRT space

DiabetesObesity

The 3 Horizons for Growth

Page 34: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

USA IsraelJapan

The largest medical device market

Ageing population

Center of

ExcellenceAgeing population

Advanced medicineEndothelial function

awareness

Strategic Focus – by Geographic Regions

Page 35: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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 HighlightsDevelopment of Arterial Function Study

Page 36: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Investment HighlightsDevelopment 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

Page 37: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Financials

Page 38: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014
Page 39: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Business Model

Shaul to add tonight

Page 40: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Thank you!

Page 41: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

41

2004 2007 2010

0.0

100.0

200.0

300.0

400.0

500.0

600.0

700.0

800.0

900.0

1000.0

1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Sales, $, Million

Acquired SteriOssMarket 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

Page 42: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

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

Page 43: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

The Problem: cardiology-related readmissions

• Post-stenting

• Unexplained chest pain

• Heart failure

* Source: American Heart Association, 2010

Heart failure

Heart attack

Pneumonia Circulatory system

disorders

Other

24.70%

19.90% 18.30%

10.40%

26.70%

* Source: Agency for Healthcare Research and Quality WSJ article “Don’t come back. Hospitals say”

Itamar’s strength

% Medicare Patients Readmitted to Hospitalsin 2010 within 30-days

Page 44: Itamar Medical Ltd. Transferring Great Science into Patient Care April 2014

Source: ResMed investor presentation Q3 2013

Drug resistant hypertension

Obesity

Congestive Heart Failure

Diabetes type 2

Stroke

Pacemakers

Arrhythmias

Coronary heart disease

Atrial Fibrillation

Depression

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

83%

77%

76%

72%

63%

59%

58%

57%49%

45%

Itamar’s Potential Market Beyond the Traditional Sleep Market