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A FAMILY GUIDE TO
CARDIAC STEM CELL
THERAPY
Restore Flow;
Restore Life
Interventional Cardiologist, over 25 years
• University of Georgia, BS
• Medical College of Georgia, M.D.
• Emory University, MBA.
• Vanderbilt University, Fellowship
Former Chief, Cardiac Sciences, Saint
Thomas Hospital, Nashville, Tennessee
American College of Cardiology, Trustee
American Heart Association, Former
President, Davison County Chapter
Howard T. Walpole, M.D.
Chief Medical Officer
Okyanos Heart Institute
More than 17,000 cardiac catheterizations
Howard T. Walpole, MD, MBA, FACC, FACAI
Chief Medical Officer
Leslie Miller, MD, FACC
Chief Science Officer, Okyanos
Chair, Department of Cardiovascular Medicine,
University of South Florida (USF)
Director/CEO , USF Cardiovascular Clinical and
Research Integrated Strategic Program
World-renowned cardiologist, specifically in the
areas of heart failure and transplant.
Former Director, Cardiac Programs, Georgetown
University School of Medicine, Georgetown
University Hospital and Washington Hospital Center.
Professor/Director, Cardiovascular Division,
University of Minnesota.
Investigator in over 80 clinical
trials including the use of
adipose-derived stem and
regenerative cells for the
treatment of cardiovascular
disease.
Gretchen Dezelick, RN, BSN, CNOR, LHCRM
Director of Nursing
Over 25 years of nursing
experience
Certified Critical Care Nurse
(CCRN) for more than 20 years
Certified Peri-Operative Nurse
(CNOR)
Licensed Healthcare Risk Manager
(LHCRM)
Oversees care delivery & safety
standards
Represents nursing as a member
of the senior leadership team
R.N., St. Joseph Hospital School
of Nursing, Lancaster, PA
BSN, Millersville State
University, PA
• American Association of
Critical Care Nurses
• Association for Professionals in
Infection Control
• Association of Peri-Operative
Registered Nurses
• Florida Society of Healthcare
Risk Managers
• American Society for
Healthcare Risk Management
and Ambulatory Surgery
Center Association.
Beyond Bypass Surgery
and Stents
Cell Therapy is the Next Generation
of Medicine
Okyanos Heart Institute
Medical Advisory Council
Eric Duckers, MD, PhD, FESC, FACC
Erasmus University, Netherlands
Leslie Miller, MD, FACC
University of South Florida
Farrell Mendelsohn, MD, FACC
Center for Therapeutic Angiogenesis
Antonio Colombo, MD,
FACC
Columbus Hospital, San
Raffaele Hospital
Evolution of Medicine
Cardiac stem cell therapy promises to be a new
phase in the treatment of coronary artery disease.
Past Future
Ischemic Diseases
Stroke
Cardiac
Diabetic Wounds
PVD
Radiation and Other
Chronic Wounds
10
EU
FDA
EU Ahead of FDA with Comparable Safety
An English Speaking Country Recognizing
European Union (EU) Standards Convenient
to No-Option Patients
The Clinical Trials
Demonstrates Safety
and Better Quality of Life
PRECISE: Sustained Functional Benefit
Direct Injection Into Heart Muscle via Catheter
19
15.5
15.3
16.6
17.2 17.1
14.0
15.0
16.0
17.0
18.0
19.0
20.0
Baseline 6 Months 18 Months
Control
Cell
MVO2(%)
p < 0.05 p < 0.05
Transplant
Okyanos Treatment
• Unique mixture of stem and regenerative cells. Trial
evidence demonstrates that new blood vessels begin, and
damaged heart muscle starts to heal itself.
• Boosts your body's ability to heal itself.
• Delivered via a catheter into the heart for optimal placement
vs. a syringe passing through bloodstream.
• Derived from adipose tissue with 2400 times
more stem cells than from bone marrow.
•Only EU Approved cell-processing device available today.
Adipose Derived Regenerative Cells
(ADRCs)
Celution™ is an approved European
Union
cell processing device.
“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.”
Francisco Fernandez-Aviles
MD, PhD
We Know..
Many Trial Patients
Are Living Better &
Longer than Expected
Cardiac Cell
Therapy is Not (Yet)
a “Cure”
Not dancing isn’t an option
Are You a Candidate?
When to consider cell therapy?
 For continuing symptoms of heart failure despite bypass
surgery and/or stents, such as shortness of breath and
chest discomfort.
 In patients with progressively worsening heart function with
or without symptoms.
 For patients with evidence of inadequate cardiac blood flow.
A Partnership with Your Physician
Full Medical Screening
22 Minute Flight From Florida
to Freeport, Bahamas
Day
1
Visit Okyanos
Heart Institute Clinic
Day
2
Procedure Day
Day
3
Day of Rest
Day
4
Final Clinic Visit
& Return Home
Day
5
Determination For a Better
Quality of Life
With Cardiac Cell Therapy
U.S. cardiology team
quality of life
research
sterile, modern cath lab
easy access
short recovery
a new standard of care

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Okyanos Heart Institute Stem Cell Therapy Educational Seminar

  • 1. A FAMILY GUIDE TO CARDIAC STEM CELL THERAPY Restore Flow; Restore Life
  • 2. Interventional Cardiologist, over 25 years • University of Georgia, BS • Medical College of Georgia, M.D. • Emory University, MBA. • Vanderbilt University, Fellowship Former Chief, Cardiac Sciences, Saint Thomas Hospital, Nashville, Tennessee American College of Cardiology, Trustee American Heart Association, Former President, Davison County Chapter Howard T. Walpole, M.D. Chief Medical Officer Okyanos Heart Institute More than 17,000 cardiac catheterizations Howard T. Walpole, MD, MBA, FACC, FACAI Chief Medical Officer
  • 3. Leslie Miller, MD, FACC Chief Science Officer, Okyanos Chair, Department of Cardiovascular Medicine, University of South Florida (USF) Director/CEO , USF Cardiovascular Clinical and Research Integrated Strategic Program World-renowned cardiologist, specifically in the areas of heart failure and transplant. Former Director, Cardiac Programs, Georgetown University School of Medicine, Georgetown University Hospital and Washington Hospital Center. Professor/Director, Cardiovascular Division, University of Minnesota. Investigator in over 80 clinical trials including the use of adipose-derived stem and regenerative cells for the treatment of cardiovascular disease.
  • 4. Gretchen Dezelick, RN, BSN, CNOR, LHCRM Director of Nursing Over 25 years of nursing experience Certified Critical Care Nurse (CCRN) for more than 20 years Certified Peri-Operative Nurse (CNOR) Licensed Healthcare Risk Manager (LHCRM) Oversees care delivery & safety standards Represents nursing as a member of the senior leadership team R.N., St. Joseph Hospital School of Nursing, Lancaster, PA BSN, Millersville State University, PA • American Association of Critical Care Nurses • Association for Professionals in Infection Control • Association of Peri-Operative Registered Nurses • Florida Society of Healthcare Risk Managers • American Society for Healthcare Risk Management and Ambulatory Surgery Center Association.
  • 5. Beyond Bypass Surgery and Stents Cell Therapy is the Next Generation of Medicine
  • 7. Medical Advisory Council Eric Duckers, MD, PhD, FESC, FACC Erasmus University, Netherlands Leslie Miller, MD, FACC University of South Florida Farrell Mendelsohn, MD, FACC Center for Therapeutic Angiogenesis Antonio Colombo, MD, FACC Columbus Hospital, San Raffaele Hospital
  • 8. Evolution of Medicine Cardiac stem cell therapy promises to be a new phase in the treatment of coronary artery disease. Past Future
  • 10. 10 EU FDA EU Ahead of FDA with Comparable Safety An English Speaking Country Recognizing European Union (EU) Standards Convenient to No-Option Patients
  • 11. The Clinical Trials Demonstrates Safety and Better Quality of Life
  • 12. PRECISE: Sustained Functional Benefit Direct Injection Into Heart Muscle via Catheter 19 15.5 15.3 16.6 17.2 17.1 14.0 15.0 16.0 17.0 18.0 19.0 20.0 Baseline 6 Months 18 Months Control Cell MVO2(%) p < 0.05 p < 0.05 Transplant
  • 13. Okyanos Treatment • Unique mixture of stem and regenerative cells. Trial evidence demonstrates that new blood vessels begin, and damaged heart muscle starts to heal itself. • Boosts your body's ability to heal itself. • Delivered via a catheter into the heart for optimal placement vs. a syringe passing through bloodstream. • Derived from adipose tissue with 2400 times more stem cells than from bone marrow. •Only EU Approved cell-processing device available today.
  • 14. Adipose Derived Regenerative Cells (ADRCs) Celution™ is an approved European Union cell processing device. “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.” Francisco Fernandez-Aviles MD, PhD
  • 15. We Know.. Many Trial Patients Are Living Better & Longer than Expected Cardiac Cell Therapy is Not (Yet) a “Cure”
  • 16. Not dancing isn’t an option
  • 17. Are You a Candidate?
  • 18. When to consider cell therapy?  For continuing symptoms of heart failure despite bypass surgery and/or stents, such as shortness of breath and chest discomfort.  In patients with progressively worsening heart function with or without symptoms.  For patients with evidence of inadequate cardiac blood flow.
  • 19. A Partnership with Your Physician
  • 21. 22 Minute Flight From Florida to Freeport, Bahamas Day 1
  • 25. Final Clinic Visit & Return Home Day 5
  • 26. Determination For a Better Quality of Life With Cardiac Cell Therapy
  • 27.
  • 28. U.S. cardiology team quality of life research sterile, modern cath lab easy access short recovery a new standard of care