itamar medical · 8 . the traditional sleep market – usa * sleep testing volumes and...
TRANSCRIPT
Itamar Medical
Investors Presentation June 2016
2
Disclaimer
Itamar 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, regulatory changes, delay or withholding of regulatory approvals, inability to obtain or maintain medical insurance reimbursement fro Company's products, negative results of clinical trials 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.
3
Itamar Medical
• Publicly traded (TASE:ITMR) since 2007 • HQ, R&D and production in Israel (140 employees) • Product lines
• WatchPAT™ Ambulatory sleep disorders & Total Sleep Solution
• EndoPAT™ Early detection and risk assessment of cardiovascular disease
• Main Markets • US, Japan, China & Europe
• Sales • 2015: $16.8M
Itamar Medical Corporate HQ
Itamar Medical HQ (Franklin, MA)
Itamar Medical Japan HQ (Tokyo)
Note: The above reflect the holdings rates as of March 31, 2016
4
Itamar Medical’s Proprietary Technology Health Being Made Simple
EndoPAT™
WatchPAT™
The arterial endothelial system
The autonomic nervous system
5
Sleep: WatchPAT™
Simply Transforming Sleep Management
6
A Better Way to Diagnose Sleep Apnea
6
Spend a night in a lab
Requires skilled staff
Sleep in your own bed
Easy self-administration
Polysomnography (PSG) WatchPAT™
7
Sleep Apnea - a significant comorbidity to most cardiac disease directly increasing medical costs**
• Major Prevalence ~25% of adult population* or 60 million Americans, of which ~40 million undiagnosed*
• Treatment options readily available:
* Source: American Academy of Sleep Medicine, Peppard, et al., American Journal of Epidemiology (2013)
** Seet & Chung, Anestsiology Clin 2010
CPAP Surgery Oral Appliance
Normal Breathing Airway is open, Air flows freely to lungs
Obstructive Sleep Apnea Airway collapses, Blocked air flow to lungs
Obstructive Sleep Apnea (OSA)
8
The Traditional Sleep Market – USA
*Sleep Testing Volumes and Reimbursement in the United States; Frost & Sullivan , August 13th, 2014,
“Obstructive Sleep Apnea is expected to grow during 2014-2018 at one of the fastest rates among all Medical Technologies” (Goldman Sachs Research)
Number of Sleep Tests Performed (M)*
Lab
Lab
Lab
Home Test
Home Test
9
A Paradigm Shift to Home Sleep Testing
Current Disadvantages ? Not with WP !
10
Simplicity of Pulse Oximetry, Accuracy of PSG
8+ parameters
+ sleep stages,
+ true sleep time
Home PSG
4-5 parameters
AHI, RDI, snoring, position
Cardio Pulmonary Systems
1-2 parameters
saturation
motion
Pulse Oximetry
SIMPLICITY / COMFORT
Embla, Aura-Grass, Philips Alice Pdx
Embletta, ARES, Philips Stardust, Resmed Apnea link, Carefusion Nox T3,
Cadwell ApneaTrak
Nonin, Masimo
Lab PSG Test completion rate
98% vs 80%* Misdiagnosis 3% vs 20%**
Auto-detection of Central Apnea mix***
WatchPAT™
“ US and European Sleep Disorder Diagnostic Devices Market “, Frost & Sullivan ; M9AC-54 February 2014 ** Comparison of Apnea Hypopnea Index (AHI) Using Recording Time vs. Sleep Time”; Schutte-Rodin; SLEEP Volume 37, 2014 *** FDA submission June 8th 2016 – pending FDA clearance
PAR
AM
ETER
S
11
Sleep Apnea - a Significant Comorbidity to Most Cardiac Disease
• Source: Seet & Chung, Anestsiology Clin 2010
83%
76%
72%
63%
59%
58%
57%
49%
45%
Drug resistant hypertension
Congestive heart failure
Diabetes typ 2
Stroke
Pacemakers
Arrhythmias
Coronary heart disease
Atrial fibrillation
Depression
7.2
5.1
29.0
6.4
3.5
14.4
16.2
3.5
40.0
OSA Comorbidity US patients M
e
12
Providing a Solution to an Unmet Need in Cardiology
Sleep apnea (OSA)
Primary symptoms: snoring, fatigue
Secondary impact: cardiology comorbidity
Traditional “sleep market”
Underserved cardiology market
Pulmonologists Cardiologists
Complex, uncomfortable
sleep lab tests with long wait times
MISSING: a full solution
for the cardiology department
13
Treatment of OSA Reduces Cardiovascular Disease Readmission
• Upenn Schwab,et el Journal of Clinical Sleep medicine, Oct 2014
PAP compliance:
Cardiovascular patients with OSA: • Heart failure • Arrhythmias • Mayocordial
infarction
Non-readmission probability
14
Treatment of OSA Reduces AFib Recurrence Post Ablation
36.7%
71.9%
66.7%
Atrial fibrillation patients after a
catheter ablation
Sleep apnea, not treated
Sleep apnea, treated
No sleep apnea
12 months AF success rate
• Simplified results from Fein, Anter, Josephson et al. JACC July 2013
15
Treatment of OSA Reduces AFib Recurrence Post Ablation
16
Full Solution for Cardiologists – Total Sleep Solution™ (TSS)
17
TSS for AFib – a Systematic Approach: a Consensus in the Making
Electrophysiologists are increasingly acknowledging the link between atrial
fibrillation and sleep apnea. At the University of Chicago sleep physicians work with heart rhythm specialists in a
new care model that could improve patient outcomes.
Prof. Hugh Calkins, chairman of the AFib task force by HRS/AHA/ESC Director of the Electrophysiology Laboratory and Arrhythmia Service at Johns Hopkins Hospital
There is clear evidence demonstrating OSA to be a significant risk factor for AF. In
addition, treatment of OSA is an important component of AF management, particularly
when cardioversion or PVI is used. The strength of the evidence warrants consideration of routine clinical
screening for OSA prior to use of a rhythm control strategy.
Prof. Babak Mokhlesi, Director of the University of Chicago's Sleep Disorder Center
18
Partnerships
18
Sleep WatchPAT
Cardiology Sleep
AFib* Treatment
WatchPAT
Total Cardiology
Direct
WatchPAT total solution for cardiology - putting cardiac diseases to sleep
*Core sleep US is still a significant base and revenue growth source
Co-Marketing
Distribution
CPAP TX for Cardio
ITMR Distribution
Patient Screening &
Referral
Sleep Study
Study Interpretation
Treatment TSS
Reimbursement
Reimbursement
Reimbursement
19
Vascular Health: EndoPAT
Simply Assessing Vascular Health
20
Traditional Risk Factors are not Effective in Predicting Heart Attacks
FACT: >50% of coronary deaths* had NO previous symptoms
FACT: ~50% of heart attacks
were NOT “high risk”!
* 64% of women who died suddenly had no symptoms! AHA 2014 Statistics
EndoPAT was proven to be an independent risk factor for heart disease
21
How Does the EndoPAT Test Work?
15 min Short test at the physician’s office
Non-invasive Measurement with fingertip sensors
Immediate Results automatically generated
Operator Independent
Easy to Use
Proven as Independent Risk Factor
The only non-invasive test FDA cleared for Endothelial Dysfunction testing
22
Early Detection of Underlying Disease Progression
Endothelial Dysfunction
Primary Secondary
Prevention
23
Addressing Clinical Needs
• A novel, independent risk factor that may be used for re-stratification of patients
New Risk Factor
• Monitoring and optimization of treatment effectiveness
Treatment Titration
• Monitoring of patients’ compliance to given treatment
Patient Compliance
24
Clinical Indications
Cardio Vascular Disease (CVD) – EndoPAT serves as a predictor of CVD and in identifying near-future cardiac risk
Diabetes - EndoPAT is the only device that can assess the micro vessel function - a key component in diabetes
Women's Health - EndoPAT effectively helps identify high-risk women who present atypical symptoms and can otherwise go undiagnosed
Erectile Dysfunction (ED) – EndoPAT can attest that the ED is a manifestation of endothelial dysfunction
Smoking Cessation - EndoPAT acts as a strong motivating tool to convince patients to stop smoking and monitor their progress
Occupational Screening – EndoPAT can act as a health screening tool for employers/payers
Thank You!