Itamar Medical Ltd Investor Presentation January 2014.

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Itamar Medical Ltd Investor Presentation January 2014

Transcript of Itamar Medical Ltd Investor Presentation January 2014.

Page 1: Itamar Medical Ltd Investor Presentation January 2014.

Itamar Medical Ltd Investor Presentation

January 2014

Page 2: Itamar Medical Ltd Investor Presentation January 2014.

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.

Page 3: Itamar Medical Ltd Investor Presentation January 2014.

Mission

Vision

Improving Health Through the PAT™ Signal

Making the PAT™ Signal Standard of Care

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The Scientific Foundations- Endothelial Function Research EvolutionDevelopment of Arterial Function Study

Furchgott, Ignarro & Muraddiscover Nitric-Oxide’s role

in CV regulation.Nobel Prize awarded in 1998

Ganz’s group assessintra-coronary endothelial

function

Celermajer & Deanfielddescribe technique of ultrasonic

assessment of Flow Mediated Dilation

Lerman’s group validateEndo-PAT2000 with

intra-coronary AcetylCholine

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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

+ ALGO

RYTHM

S

Sleep

Heart

WatchPAT™

EndoPAT™

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USAThe largest medical

device market Ageing population

ISRAELCenter of Excellence

JAPANAgeing population

Advanced medicineEndothelial function

awareness

Strategic Focus – by Geographic Regions

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Organizing & Leveraging

Existing Business

The Road Ahead

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Turn Sales force to CallOn Clinical Accounts

Salesforce expansion Organic and channels Focus on NYC

Financing & Rent options

Reimbursement

Focus on the US

Leadership

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Organizing & Leveraging

Existing Business

The Road Ahead

Grow WatchPAT™

Marketand

Channels

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Sleep Market in the USA 2010 vs. 2016

*-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

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

83%

77%

76%

72%

63%

59%

57%

49%

45%

Drug Resistance HypertensionObesity

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

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Clinical Studies– OSA and AF

Treatment of obstructive sleep apnea reduces the risk of atrialfibrillation recurrence after catheter ablation (Fein et al, JACC July 2013)

Dr. Mark Josephson Beth Israel

#pts30323022

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.

Page 13: Itamar Medical Ltd Investor Presentation January 2014.

The Sleep Market Does Not Meet the Needs of Cardiology Patients

3000Few Dominant

ProvidersLimited Number of

Sleep Docs

Un-served Cardiology Market

220k Ablations is 2014~3M Patients with A.Fib

EVIDENCE

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Serving an Unmet Need

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Itamar’s Plan to Serve the Cardiology Market

A.Fib OEM ~1200 Reps

HST + IT Solution

Few DominantProviders

Limited Number of Sleep Docs

220k Ablation is 20143M Patients with A.Fib

EVIDENCE

Home service providers for OSA

treatmente.g. VGM

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95% of sleep studies performed at the labBecause HST has not been accepted by authorities as an

accurate sleep-stages diagnostic tool or considered too cumbersome

The Japanese Sleep Market

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Organizing & Leveraging

Existing Business

The Road Ahead

Grow WatchPAT™

MarketAnd

Channels

EndoPAT™Adding the

Ripe Secondary Prevention

segment

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Go A S et al. Circulation 2013;127:e6-e245מקור

US: Direct and Indirect Costs of Cardiovascular Disease $ billions in 2010

Source: Go A S et al. Circulation 2013;127:e6-e245

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Time to Market

Care continuum

5-10 years

now

Post-diagnosis Prevention

1-2years

US Potential Market Segments

Primary preventionFramingham Risk Index

Enhancement217m 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”

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Time to Market

Care continuum

5-10 years

now

Post-diagnosis Prevention

1-2years

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 preventionFramingham Risk Index

Enhancement217m

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Time to Market

Care continuum

5-10 years

now

Post-diagnosis Prevention

1-2years

US Potential Market Segments*

“Be as important as the cholesterol test today”

“People who are health conscious”

Existing and mature

professional market

Primary PreventionFramingham Risk Index

Enhancement217m

Wellness and Early Detection

76mDiagnosis of Sleep Apnea

58m

Secondary Prevention &

monitoring post Cardiac Event

16mTargeting

Cardiologist(22,000)

“Symptomatic heart patients or post

cardiac event patients”

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Time to Market

Care continuum

5-10 years

now

Post-diagnosis Prevention

1-2years

* USA Markets Only

US: Adding the Cardiology Market in the Short Term

CPT codes old– 93922 / 939230337T (Cat III)- as of Jan 1st 2014

INSURANCE COVERAGE

Primary preventionFramingham Risk Index

Enhancement217m

Wellness and Early detection

76mCompleted published studiesKITTARUBINSTEINMODENAMatsuzawa X2Matsue

Secondary Prevention &

monitoring post Cardiac Event

16mTargeting

Cardiologist(22,000)

Diagnosis of sleep apnea

58m

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Major Clinical StudiesRelated to the Cardiology Market

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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 Population Unique EndoPAT™ ValueStudy Outcome

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Symptomatic Patients with Chest Pain

Current market segment: using EndoPAT™ in cardiac patients where standard tests fail to diagnose

8.9M PatientsShowing 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

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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 Population Unique 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

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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 Population Unique 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)

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The EndoPAT® is Used by US Leading Cardiologists

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Supporting Mega Trends

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The Healthcare Reform for Better Value Health CareThe program for readmissions reduction

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”

The Program focus

% Medicare Patients Readmitted to Hospitals in 2010 within 30-days

Page 31: 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

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Focus, Focus and Focus

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Thank You!

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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 .

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Sleep Disorder DiagnosticsHow is a sleep disorder diagnosed?

Do you prefer a lab test … or at home?

PSG WatchPAT™