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Itamar Medical Ltd Investor Presentation January 2014

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Itamar medical ltd investor presentation january 2014

Itamar Medical Ltd

Investor Presentation

January 2014


Disclaimer

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


Itamar medical ltd investor presentation january 2014

Mission

Improving Health

Through the PAT™ Signal

Vision

Making the PAT™ Signal Standard of Care


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

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™


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

The Road Ahead

Organizing & Leveraging

Existing

Business


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

The Road Ahead

Grow WatchPAT™

Market

and

Channels

Organizing & Leveraging

Existing

Business


Sleep market in the usa 2010 vs 2016

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


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

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.


The sleep market does not meet the needs of cardiology patients

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


Serving an unmet need

Serving an Unmet Need


Itamar s plan to serve the cardiology market

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


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

The Road Ahead

EndoPAT™

Adding the Ripe Secondary Prevention segment

Grow WatchPAT™

Market

And

Channels

Organizing & Leveraging

Existing

Business


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

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


Major clinical studies related to the cardiology market

Major Clinical StudiesRelated to the Cardiology Market


Itamar medical ltd investor presentation january 2014

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


Itamar medical ltd investor presentation january 2014

  • 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


Itamar medical ltd investor presentation january 2014

  • 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


Itamar medical ltd investor presentation january 2014

  • 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


Itamar medical ltd investor presentation january 2014

The EndoPAT® is Used by US Leading Cardiologists


Itamar medical ltd investor presentation january 2014

Supporting Mega Trends


Itamar medical ltd investor presentation january 2014

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”


Itamar medical ltd investor presentation january 2014

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


Focus focus and focus

Focus, Focus and Focus


Itamar medical ltd investor presentation january 2014

Thank You!


Itamar medical ltd investor presentation january 2014

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.


Itamar medical ltd investor presentation january 2014

How is a sleep disorder diagnosed?

Do you prefer a lab test … or at home?

PSG

WatchPAT™


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