Automating RIC

Automating RIC
Across the Spectrum of Care
Rocky Ganske, CEO
OneMed 2013 1
Heart disease – leading cause of death
PROTECTING
HEART CELLS IS
CRITICAL
2
One attack: two dangers
Ischemic damage
Reperfusion damage
Acute stage
3
Cells continue to die after heart restarts
Ischemic damage
T0 heart attack
Reperfusion damage
Day 1
Day 2
Day 3
Day 4
Evolving damage
4 4
4
The body has
an innate process
to protect itself
when threatened
by injury
5
Clinical Background
Local IPC
Remote IPC
Transient Cx ischemia→Cx protection Transient Cx ischemia→LAD protection
Potent cytoprotection
~50% reduction in infarct size
Limited clinical utility
Murry CE, Jennings RB, Reimer KA.
Circulation. 1986 Nov;74(5):1124-36
Przyklenk K, Bauer B, Ovize M, Kloner RA, Whittaker P.
Circulation. 1993 Mar;87(3):893-9
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Clinical Background
Local IPC
Remote IPC
Transient Cx ischemia→Cx protection
Inter-organ e.g. Kidney/Mesentery→Heart
Murry CE, Jennings RB, Reimer KA.
Circulation. 1986 Nov;74(5):1124-36
Gho BC, Schoemaker RG, van den Doel MA, Duncker DJ,
Verdouw PD. Circulation. 1996 Nov 1;94(9):2193-200.
7
Clinical Background
Local IPC
Remote IPC
Inter-organ Limb→Heart
Transient Cx ischemia→Cx protection
Murry CE, Jennings RB, Reimer KA.
Circulation. 1986 Nov;74(5):1124-36
Kharbanda RK et al.
Circulation. 2002 Dec;106(23):2881-3
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Automating Remote Ischemic Conditioning
1) Restrict blood flow
2) Triggers release
cytoprotective factor
3) Cytoprotective factors
4X
•
Increase cellular O2
•
Reduce inflammation
•
Improve heart function
Cycle
Simply enabling a sophisticated biological process
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Well-researched mechanism
25 completed trials
58 ongoing trials
+
239 scientific papers
5,695 articles regarding local IC
Current trials from www.clinicaltrials.gov
0 adverse events reported
10
Current and Completed Trials
Current – 13
Completed - 10
Current – 15
Completed - 21
Current – 0
Completed - 1
Current – 11
Completed - 14
Approximately 250 papers published
11
Initial Lancet publication supports claims
N = 333 patients
40%
reduction in
the size of
myocardial infarct
RIC
Assessed upon arrival
Day 30: size &
magnitude of heart
attack measured
12
Greater than $4Billion Combined New Opportunity
Performance
Enhancement
Undiagnosed
Chest Pain
Evolving MI Calls
Trauma
Public First
Response
Post MI
Cardiac Arrest
Existing
Medical
Conditions
Acute Embolic Stroke
Elective Coronary
Angioplasty
Exercise Enhancement in
Ischemic Syndromes
ContrastMedium-Induced
Nephropathy
Cardiac Surgery
In-Stent
Restenosis
>$1.7B
Post MI
Remodeling
Solid Organ
Transplantation
Non-Cardiac
Surgery
>$2.2B
Automating RIC Across the Spectrum of Care
Insert reference or tag line
13
Beyond cardiovascular markets
Strong evidence of multi-organ protection
Brain
Lung
Liver
Kidney
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World Class Team, World Class Patents
Patents
People
SAB
Core Utility Patent
Rocky Ganske, CEO
Dr. Andrew Wechsler
•U.S. Patent No. 7,717,855 B2
System for performing remote
ischemic pre-conditioning
(Method & Apparatus)
CEO , COO -Third Wave (TWTI),
Regulatory Becton Dickinson
Highlights
•Notice of intent to grant on first
EU patent
•Core patents issued
•5 patent applications covering
new large markets
Andrew Redington
Professor & Chair of the Dept. of
Cardiothoracic Surgery, Drexel University
College of Medicine, Editor Emeritus of The
Journal of Thoracic and Cardiovascular
Surgery
Chief of Cardiology
Hospital for Sick Children
(Toronto)
Dr. Kim Fox
Christopher Caldarone
Dr. Richard Weisel
Chief of Cardiothoracic Surgery
University of Toronto
Cardiovascular Surgeon and Director of
Research, Toronto General Research
Institute
Royal Brompton Hospital and Past
President of European Society of
Cardiology
Dr. Sidney Levitsky
David W. and David Cheever Professor of
Surgery, Harvard Medical School; Director,
Cardiothoracic Surgery, CareGroup; Senior
Vice Chairman, Department of Surgery at
Beth Israel Deaconess Medical Center
Safety, convenience, time
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Status and Milestones
Current
•Core US patents issued and EU granted
• U.S. Patent No. 7,717,855 B2
•CE Mark for autoRIC device in EU
•ISO 13-485 Certified facility
Near term
•Near term licensing agreements for sub-market
•7 Investigator sponsored trials >5000 patients
•EU launch with partner
•Health Canada license approval
•Initiation of US FDA trial
•Initial Health Economics Outcomes
Insert referenceSignificant
or tag line
short term value accretion
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Strong adoption drivers
1. Adjunct therapy
2. Low cost
3. Low risk
4. Huge benefit
5. Huge savings
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Reward
Risk
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