okyanos heart institute cardiac cell therapy 120319103208 phpapp02 (3)
TRANSCRIPT
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
OKYANOS Heart Institute ©2012 All Rights Reserved
Evolution of Medicine
Surgery Drugs Devices Stem andRegenerative Cells
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OKYANOS Heart Institute ©2012 All Rights Reserved
“When someone says they don’t believe in stem cells they don’t understand their own development. We’re walking stem cell products.”
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OKYANOS Heart Institute ©2012 All Rights Reserved
Epiphany
“You would expect cells that do vascular things to improve blood flow. Bingo, they improve blood flow.”
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OKYANOS Heart Institute ©2012 All Rights Reserved
Ischemic Conditions
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Stroke
Cardiac
Crohn’s Fistulas
Diabetic Wounds
PVD
Radiation and Other Chronic Wounds
OKYANOS Heart Institute ©2012 All Rights Reserved
Ischemic Heart Disease
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OKYANOS Heart Institute ©2012 All Rights Reserved
ADRCs
“Fresh cells from adipose-tissue using the Celution™ system seems to have the most dramatic results of any cell therapy study I have seen in Chronic Ischemic Heart Disease.”
Celution™ is not approved
for use in the U.S.
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OKYANOS Heart Institute ©2012 All Rights Reserved
PRECISE: Sustained Functional Benefit
MV
O2
(%)
p < 0.05 p < 0.05
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Transplant
OKYANOS Heart Institute ©2012 All Rights Reserved
Cell Society Feb., 2011
Expected EU-Approval
for No-Option CMI
Providing Cardiac Cell Therapy
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OKYANOS Heart Institute ©2012 All Rights Reserved
EU Ahead of FDA with Comparable Safety Profile
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EU
FDA
Okyanos Heart Institute ©2012 All Rights Reserved
OKYANOS Heart Institute ©2012 All Rights Reserved
What Don’t We Know
Optimal # of Treatments
Optimal Delivery Method
Optimal Dosage
Optimal Cell Type
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OKYANOS Heart Institute ©2012 All Rights Reserved
What We Do Know
Cardiac Cell Therapy is Not (Yet)
a “Cure”
Many Trial Patients Are Living Better &
Longer than Expected
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OKYANOS Heart Institute ©2012 All Rights Reserved
Patients
Improved
Heart
Function
Reduced
MACCE and
Hospitalization
Better
Quality
of Life
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OKYANOS Heart Institute ©2012 All Rights Reserved
Center of
Excellence
What Patients Expect
Celution One™
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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OKYANOS Heart Institute ©2012 All Rights Reserved
OKYANOS Heart Institute
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OKYANOS Heart Institute ©2012 All Rights Reserved 16
A Better Quality of Life for Patients with No-Option
A New Standard of Care;
OKYANOS Heart Institute ©2012 All Rights Reserved
OKYANOS Cardiac Cell-Therapy
OKYANOS Heart Institute ©2012 All Rights Reserved
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 Spring, 2012
OKYANOS Heart Institute
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