okyanos heart institute - cardiac cell therapy

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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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The Okyanos Heart Institute brings a new standard of care and a better quality of life to patients with “no-option” coronary artery disease (CAD), utilizing a European Union–approved cell processing device.

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Page 1: Okyanos Heart Institute - Cardiac Cell Therapy

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

Page 2: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 2

Evolution of Medicine

Surgery Drugs Devices Stem andRegenerative Cells

Page 3: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 3

“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

Page 4: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 4

Ischemic Conditions

Stroke

Cardiac

Crohn’s Fistulas

Diabetic Wounds

PVD

Radiation and Other Chronic Wounds

Page 5: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 5

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

Page 6: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 6

What Don’t We Know

Optimal # of Treatments

Best Delivery Method

Optimal # of Cells

Best Cell Type

Page 7: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 7

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

Page 8: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 8

Patients

What Really Matters

Reduced Mortality

ReducedMACCE and

Hospitalization

Improved Qualityof Life

Page 9: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 9

Cell Society Feb., 2011

Cytori Expects EU-Approvalfor No-Option CMI

The Need for a Provision of Healthcare Service

Page 10: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 10

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

Page 11: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 11

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

Page 12: Okyanos Heart Institute - Cardiac Cell Therapy

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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.

Page 13: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 13

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

Page 14: Okyanos Heart Institute - Cardiac Cell Therapy

OKYANOS Heart Institute ©2012 All Rights Reserved 14

OKYANOS Heart Institute