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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.
Mission
Vision
Improving Health Through the PAT™ Signal
Making the PAT™ Signal Standard of Care
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
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™
USAThe largest medical
device market Ageing population
ISRAELCenter of Excellence
JAPANAgeing population
Advanced medicineEndothelial function
awareness
Strategic Focus – by Geographic Regions
Organizing & Leveraging
Existing Business
The Road Ahead
Turn Sales force to CallOn Clinical Accounts
Salesforce expansion Organic and channels Focus on NYC
Financing & Rent options
Reimbursement
Focus on the US
Leadership
Organizing & Leveraging
Existing Business
The Road Ahead
Grow WatchPAT™
Marketand
Channels
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
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
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.
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
Serving an Unmet Need
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
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
Organizing & Leveraging
Existing Business
The Road Ahead
Grow WatchPAT™
MarketAnd
Channels
EndoPAT™Adding the
Ripe Secondary Prevention
segment
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
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”
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
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”
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
Major Clinical StudiesRelated to the Cardiology Market
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
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
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
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)
The EndoPAT® is Used by US Leading Cardiologists
Supporting Mega Trends
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
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
Thank You!
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 .
Sleep Disorder DiagnosticsHow is a sleep disorder diagnosed?
Do you prefer a lab test … or at home?
PSG WatchPAT™