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“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 and
                                                                 Regenerative Cells



OKYANOS Heart Institute ©2012 All Rights Reserved                                 2
“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.”




OKYANOS Heart Institute ©2012 All Rights Reserved      3
Ischemic Conditions
                  Stroke


                  Cardiac


                  Crohn’s Fistulas



                                                        Radiation and Other
                                                           Chronic Wounds


                                                                      PVD


                                                          Diabetic Wounds

OKYANOS Heart Institute ©2012 All Rights Reserved                         4
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.”




OKYANOS Heart Institute ©2012 All Rights Reserved                 5
What Don’t We Know




                                            Optimal #                     Best Delivery
                                             of Cells                       Method
                                                            Optimal
      Best Cell Type
                                                        # of Treatments




OKYANOS Heart Institute ©2012 All Rights Reserved                                         6
What We Do Know


                                                    Consistent, Strong,
                                                     Improving Signals
                         Cardiac Cell                 of Efficacy from
                      Therapy is Not (Yet)          Clinical Trials which
                           a “Cure”                 Treated over 1000
                                                        Patients with
                                                    Mesenchymal Cells




OKYANOS Heart Institute ©2012 All Rights Reserved                           7
Patients




                                                    Improved Reduced
                        Reduced
                        Mortality
                                                     Quality MACCE and
                                                      of Life Hospitalization




OKYANOS Heart Institute ©2012 All Rights Reserved                                8
The Need for a Provision of Healthcare Service




                                                    Cell Society Feb., 2011



                                                    Cytori Expects EU-Approval
                                                    for No-Option CMI



OKYANOS Heart Institute ©2012 All Rights Reserved                                9
PRECISE: Sustained Functional Benefit


                       20.0                                                  Control
                                                                             Cell
                       19.0   19
                                                      p < 0.05   p < 0.05
                       18.0
            MVO2 (%)




                                                       17.2        17.1
                       17.0
                              16.6
                       16.0

                       15.0                            15.5
                                                                   15.3
                                                    Transplant
                       14.0
                         Baseline                    6 Months    18 Months



OKYANOS Heart Institute ©2012 All Rights Reserved                                   10
PRECISE: Sustained Functional Benefit




                                                                          Safe and       Lower
                                                         Infarct          Feasible      Cardiac
      MVO2                          METS
                                                          Size            Through       Mortality
                                                                         18 Months        Rate


Significant Change          Significant Change        8.2% Change                    At Avg. Follow Up
   at 18 Months                at 18 Months            at 6 Months                     of 28 Months:

   Correlates to                                    Significant Change                2/6 Placebo Pts
Improved Survival                                                                     Died of Cardiac
                                                                                          Causes

   ≤ 14 = 47%                                                                         1/21 Treated Pts
1 Yr Survival Rate                                                                    Died of Cardiac
                                                                                          Causes




OKYANOS Heart Institute ©2012 All Rights Reserved                                               11
What Patients Expect

                                                             Chief
                                                            Medical
                                                            Officer
                                                                            Cell
                                         Next-Gen                        Processing
                                         Catheter                          Device




                                                                                  U.S.
                                 State of
                                  the Art
                                                          Center of             Surgical
                                                                                Center
                                 Cath Lab
                                                         Excellence            Standards



                                            EU-
                                          Approved                        Patient
                                          Therapy                         Registry
                                         (Expected)        Hospitality
                                                            Trained-
                                                              Staff


                  Celution One is not approved in U.S.

OKYANOS Heart Institute ©2012 All Rights Reserved                                          12
OKYANOS Heart Institute


                  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 ©2012 All Rights Reserved                                  13
OKYANOS Heart Institute




OKYANOS Heart Institute ©2012 All Rights Reserved                       14

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Okyanos Heart Institute - Cardiac Cell Therapy

  • 1. “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
  • 2. Evolution of Medicine Surgery Drugs Devices Stem and Regenerative Cells OKYANOS Heart Institute ©2012 All Rights Reserved 2
  • 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.” OKYANOS Heart Institute ©2012 All Rights Reserved 3
  • 4. Ischemic Conditions Stroke Cardiac Crohn’s Fistulas Radiation and Other Chronic Wounds PVD Diabetic Wounds OKYANOS Heart Institute ©2012 All Rights Reserved 4
  • 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.” OKYANOS Heart Institute ©2012 All Rights Reserved 5
  • 6. What Don’t We Know Optimal # Best Delivery of Cells Method Optimal Best Cell Type # of Treatments OKYANOS Heart Institute ©2012 All Rights Reserved 6
  • 7. What We Do Know Consistent, Strong, Improving Signals Cardiac Cell of Efficacy from Therapy is Not (Yet) Clinical Trials which a “Cure” Treated over 1000 Patients with Mesenchymal Cells OKYANOS Heart Institute ©2012 All Rights Reserved 7
  • 8. Patients Improved Reduced Reduced Mortality Quality MACCE and of Life Hospitalization OKYANOS Heart Institute ©2012 All Rights Reserved 8
  • 9. The Need for a Provision of Healthcare Service Cell Society Feb., 2011 Cytori Expects EU-Approval for No-Option CMI OKYANOS Heart Institute ©2012 All Rights Reserved 9
  • 10. PRECISE: Sustained Functional Benefit 20.0 Control Cell 19.0 19 p < 0.05 p < 0.05 18.0 MVO2 (%) 17.2 17.1 17.0 16.6 16.0 15.0 15.5 15.3 Transplant 14.0 Baseline 6 Months 18 Months OKYANOS Heart Institute ©2012 All Rights Reserved 10
  • 11. PRECISE: Sustained Functional Benefit Safe and Lower Infarct Feasible Cardiac MVO2 METS Size Through Mortality 18 Months Rate Significant Change Significant Change 8.2% Change At Avg. Follow Up at 18 Months at 18 Months at 6 Months of 28 Months: Correlates to Significant Change 2/6 Placebo Pts Improved Survival Died of Cardiac Causes ≤ 14 = 47% 1/21 Treated Pts 1 Yr Survival Rate Died of Cardiac Causes OKYANOS Heart Institute ©2012 All Rights Reserved 11
  • 12. What Patients Expect Chief Medical Officer Cell Next-Gen Processing Catheter Device U.S. State of the Art Center of Surgical Center Cath Lab Excellence Standards EU- Approved Patient Therapy Registry (Expected) Hospitality Trained- Staff Celution One is not approved in U.S. OKYANOS Heart Institute ©2012 All Rights Reserved 12
  • 13. OKYANOS Heart Institute 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 ©2012 All Rights Reserved 13
  • 14. OKYANOS Heart Institute OKYANOS Heart Institute ©2012 All Rights Reserved 14