OKYANOS Heart Institute ©2012 All Rights Reserved
“The stream of that river Okyanos, whence is risen the seed of all the immortals.”
Homer, Iliad 14.244ff
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Evolution of Medicine
Surgery Drugs Devices Stem andRegenerative Cells
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“Every human walking the planet is a stem cell product… (of) our father’s sperm and our mother’s egg…When someone says they don’t believe in stem cells they don’t understand their own development. We’re walking stem cell products.”
Dr. James Willerson President, Texas Heart Institute
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Ischemic Conditions
Stroke
Cardiac
Crohn’s Fistulas
Diabetic Wounds
PVD
Radiation and Other Chronic Wounds
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AHA Cardiac Cell-Therapy Teach-in Nov, 2010
“Also, importantly, they saw an effect of coronary flow, so that’s an index for new vessel formation, so they knew that these cells at least induced some new vessel formation, and that resulted in improved function of the heart.”
Henricus Duckers MD, PhD
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What Don’t We Know
Optimal # of Treatments
Best Delivery Method
Optimal # of Cells
Best Cell Type
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What We Do Know
Cardiac Cell Therapy is Not (Yet)
a “Cure”
Consistent, Strong, Improving Signals of Efficacy from
Clinical Trials which Treated over 1000
Patients with Mesenchymal Cells
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Patients
What Really Matters
Reduced Mortality
ReducedMACCE and
Hospitalization
Improved Qualityof Life
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Cell Society Feb., 2011
Cytori Expects EU-Approvalfor No-Option CMI
The Need for a Provision of Healthcare Service
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Baseline 6 Months 18 Months14.0
15.0
16.0
17.0
18.0
19.0
20.0
19
15.5 15.3
16.6
17.2 17.1
ControlCell
PRECISE: Sustained Functional Benefit
Direct Injection Into Heart Muscle via Catheter
MV
O2
(%)
p < 0.05 p < 0.05
Transplant
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PRECISE: Sustained Functional Benefit
At Avg. Follow Up of 28 Months:
Significant Change at 18 Months
Correlates to Improved Survival
≤ 14 = 47% 1 Yr Survival Rate
Significant Change at 18 Months
8.2% Change at 6 Months
1/21 Treated Pts Died of Cardiac
Causes
2/6 Placebo Pts Died of Cardiac
Causes
MVO2 METS Infarct Size
Safe and Feasible Through
18 Months
Lower Cardiac Mortality
Rate
Significant Change
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Center of Excellence
What Patients Expect
Cell Processing
Device
U.S. Surgical Center
Standards
Patient Registry
Hospitality Trained-
Staff
EU-Approved Therapy
(Expected)
State of the Art
Cath Lab
Chief Medical Officer
Next-Gen Catheter
Celution One is not approved in U.S.
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First in world to provide an (expected) EU-Approved cardiac cell therapy to patients with no-option ischemic heart disease
Autologous Adipose-Derived Stem and Regenerative Cells via intramyocardial injection
Center of Excellence built to OKYANOS specifications and U.S. surgical center standards in Freeport, Bahamas
Expected opening Summer, 2012
OKYANOS Heart Institute
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OKYANOS Heart Institute