Itamar Medical Ltd
Investor Presentation
January 2014
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,
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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
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(c) Itamar-Medical
Mission
Improving Health
Through the PAT™ Signal
Vision
Making the PAT™ Signal Standard of Care
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 validate
Endo-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
WatchPAT™
+ ALGORYTHMS
EndoPAT™
Strategic Focus – by Geographic Regions
USA
The largest medical
device market
Ageing population
ISRAEL
Center of
Excellence
JAPAN
Ageing population
Advanced medicine
Endothelial function
awareness
The Road Ahead
Organizing &
Leveraging
Existing
Business
Focus on the US
Turn Sales force to Call
On Clinical Accounts
Salesforce expansion
Organic and channels
Reimbursement
Financing & Rent options
Leadership
Focus on NYC
The Road Ahead
Organizing &
Leveraging
Existing
Business
Grow
WatchPAT™
Market
and
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
US Sleep Apnea Market – Co-Morbidities
83%
77%
Drug Resistance
Hypertension
Obesity
76%
Congestive Heart Failure
Type 2 Diabetes
72%
63%
Stroke
59%
Pacemakers
57%
Acute Coronary Syndrome
49%
Atrial Fibrillation
45%
100%
80%
60%
40%
Source: ResMed investor presentation Q3 2013
Depression
20%
0%
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
Dr. Mark Josephson
Beth Israel
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
Few Dominant
Providers
Limited Number of
Sleep Docs
Un-served Cardiology
Market
220k Ablations is 2014
~3M Patients with A.Fib
Serving an Unmet Need
Itamar’s Plan to Serve the Cardiology Market
Few Dominant
Providers
Home service
providers for OSA
treatment
e.g. VGM
Limited Number of
Sleep Docs
A.Fib OEM ~1200 Reps
HST + IT Solution
220k Ablation is 2014
3M Patients with A.Fib
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
The Road Ahead
Grow
WatchPAT™
Market
And
Organizing & Channels
Leveraging
Existing
Business
EndoPAT™
Adding the
Ripe
Secondary
Prevention
segment
US: Direct and Indirect Costs of Cardiovascular Disease
$ billions in 2010
Source: Go A S et al. Circulation 2013;127:e6-e245
Go A S et al. Circulation 2013;127:e6-e245‫מקור‬
US Potential Market Segments
Time to Market
5-10
years
Unique and
promising Large
market which will
mature in 3-5
years
Primary prevention
Framingham Risk Index
Enhancement
217m pts
Targeting all Physicians
(115,000)
“Be as important as the
cholesterol test today”
1-2
years
now
Care continuum
Post-diagnosis
Prevention
US Potential Market Segments
Time to Market
LONG-TERM OUTCOME STUDIES
5-10
years
1-2
years
Primary prevention
Framingham Risk Index
Enhancement
217m
Ongoing studies
FRAMINGHAM STUDY *
JACKSON Heart study**
Prevent IT Guttenberg Heart study***
KORA (Augsburg
now
Care continuum
Post-diagnosis
*5609 subjects since 2003
** 1877 subjects since 2007
*** 13,744 subjects since 2007
Prevention
US Potential Market Segments*
Time to Market
Existing and
mature
professional
market
5-10
years
“Symptomatic heart
patients or post
cardiac event patients”
1-2
years
now
Diagnosis
of Sleep
Apnea
58m
Post-diagnosis
Secondary
Prevention &
monitoring post
Cardiac Event
16m
Targeting
Cardiologist
(22,000)
Primary Prevention
Framingham Risk Index
Enhancement
217m
Wellness
and Early
Detection
76m
“Be as important as the
cholesterol test today”
“People who are health
conscious”
Care continuum
Prevention
US: Adding the Cardiology Market in the Short Term
Time to Market
5-10
years
1-2
years
now
INSURANCE COVERAGE
CPT codes
old– 93922 / 93923
0337T (Cat III)- as of Jan 1st
2014
Secondary
Prevention &
monitoring post
Cardiac Event
16m
Targeting
Cardiologist
(22,000)
Primary prevention
Framingham Risk Index
Enhancement
217m
Wellness
and Early
detection
Diagnosis
76m
of sleep Completed published studies
apnea KITTA
RUBINSTEIN
58m
MODENA
Matsuzawa X2
Post-diagnosis Matsue
* USA Markets Only
Care continuum
Prevention
Major Clinical Studies
Related to the Cardiology Market
Post-PCI Patients
Current market segment: using the EndoPAT™ to identify near-future cardiac risk
Patient Population
2.6M** Angiographies
performed in the USA
In 2010
Study Outcome
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.
Unique EndoPAT™ Value
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 .
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,
Matsazawa et al , J Am Heart Assoc. 2013
**US Markets for Interventional Cardiology Devices 2013, Millenium Research Group, 2012
Symptomatic Patients with Chest Pain
Current market segment: using EndoPAT™ in cardiac patients where standard tests fail to diagnose
Patient Population
Study Outcomes
EndoPAT™ Unique Value
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
Post Heart Attack Patients
Current market segment: using EndoPAT™ in all CAD patients that are on statin therapy
Patient Population
Study Outcomes
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).
7.6M** Post AMI
Patients Under
cardiologist followup
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
Patients were followed-up for
secondary CAE for a median of
2.7 years
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
Heart Failure Patients
Current market segment: using the EndoPAT™ to identify high-risk HF patients
Patient Population
5.1M** diagnosed heart
failure patients
(2007-2010)
Study Outcomes
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
Unique EndoPAT™ Value
Peripheral endothelial dysfunction
independently correlated with
future cardiovascular events,
adding incremental clinical
significance for risk stratification in
patients with HF.
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
The EndoPAT® is Used by US Leading Cardiologists
Supporting Mega Trends
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
26.70%
24.70%
19.90%
18.30%
10.40%
Heart
failure
Heart
attack
Pneumonia Circulatory
system
disorders
Other
* Source: Agency for Healthcare Research and Quality WSJ article “Don’t come back. Hospitals say”
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
theOnly
Only
Technology
for Clinical
Practice
EndoPAT™:
Technology
for Clinical
Practice
(192
references)
(192
references)
CLINICAL IMPLICATIONS
Extensive literature documents that endothelial dysfunction is associated with almost every condition
predisposing to atherosclerosis and cardiovascular disease.
How is a sleep disorder diagnosed?
Sleep Disorder Diagnostics
Do you prefer a lab test … or at home?
PSG
WatchPAT™