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MYOHEART US Phase I Study Interim Analysis

MYOHEART Study Flow. Clinical Sites: Columbia Presbyterian, Cleveland Clinic, Mayo Clinic, Minneapolis Heart, St. Joseph's / ACRICore Lab: Gentiae Clinical Research . 2 injections(.25 cc). 6 injections(.25 cc). 18 injections(.25 cc). . . . First Cohort (n=5). 25 x 10. 6. cells. . . 30. -. Day S

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MYOHEART US Phase I Study Interim Analysis

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    1. MYOHEART US Phase I Study Interim Analysis Pick apart the the attributes of delivery devicesPick apart the the attributes of delivery devices

    2. 5 sites: Mayo Clinic, Cleveland Clinic, Mt. Sinai (NYC), Minneapolis Heart, ACRI / St. Joseph’s (Atlanta) Interim data expected at TCT in October 2005.5 sites: Mayo Clinic, Cleveland Clinic, Mt. Sinai (NYC), Minneapolis Heart, ACRI / St. Joseph’s (Atlanta) Interim data expected at TCT in October 2005.

    3. To assess the safety and feasibility of MyoCell™ (autologous myoblasts) following implantation into myocardial tissue of CHF subjects who experienced prior MI (> 12 weeks), To assess the safety and feasibility of the MyoCath® transendocardial needle-injection catheter as a system for delivering MyoCell into myocardial tissue, and To assess the effect on myocardial structure and function of MyoCath mediated MyoCell implantation.

    4. Safety: Incidence and nature of serious adverse events (SAEs) up to 12 months (includes events related to vascular, cardiac, arrhythmic or device malfunction) Efficacy: Changes from baseline, 1, 3, 6 and 12 month intervals of regional and global LV wall thickness and function Independent database management performed by Gentiae Clinical Research. Responsibilities include core laboratory analysis (48-hour Holter, MUGA, PET Scan, Echocardiography and ECG analysis), adverse event reporting, case report form database, data management and data safety monitoring board.

    5. MYOHEART Eligibility Criteria INCLUSION Criteria Prior MI involving anterior, lateral, posterior or inferior walls > 12 weeks old at time of implant Patients with prior placement of an ICD > 30 days prior to implant NYHA Class II – III Age > 30 and < 80 years old Need for revascularization ruled out by coronary angiogram or noninvasive stress test within 6 months of screening Target region wall thickness of > 6 mm by echocardiography LVEF > 20% and < 40% by MUGA at screening Ability to walk at least 300 meters during 6-minute walk test

    6. MYOHEART Study Flow

    7. MYOHEART Baseline Profile

    8. MYOHEART Cell Product and Delivery

    9. MYOHEART Clinical Outcomes

    10. 6 patients experienced arrhythmias Adjudicated by Investigator as Not Related to Therapy Patient 506: intermittent VT 278 days post-procedure resolved with single ICD firing. Full resolution. Patient 902: atrial fibrillation with single ICD firing. Firing deemed inappropriate, anti- atrial fibrillation medication provided with full resolution. Adjudicated by Investigator as Possibly Related to Therapy Patient 701: 2 ICD firings at days 52 and 72 post procedure. Second event of sustained VT not resolved and patient expired. Patient 911: runs of NSVT through first week post-procedure. No ICD firing. Amiodarone provided, full resolution. Patient 912: runs of NSVT through first two weeks post-procedure. Amiodarone provided, full resolution. No ICD firing. Patient 914: multiple ICD firings 7 days post implant. Patient hospitalized, provided with Amiodarone, arrhythmias resolved. Patient expired approximately 5 months post-procedure due to progressive heart failure. MYOHEART: Arrhythmia

    11. MYOHEART MUGA

    12. MYOHEART: 6 minute walk

    13. MYOHEART: QOL

    14. What have we learned? Safety strongly suggested in this small study Clinical efficacy suggested re. QOL, exercise capacity Learning curves inherent in an early phase trial: Optimization of cell processing Modifications Injection technique

    15. Subject # 19: Benefit of cell labeling

    16. What have we learned? In combination with results from other non-randomized and randomized (MAGIC, SEISMIC) we have sufficient justification to proceed to a pivotal, clinical end-point trial: Randomized, double-blinded, placebo-controlled study Unique design features: Serial injections: 2 sessions, 4 weeks apart Cross-over: First dose – placebo controlled Second dose – both groups treated

    17. Contributors Investigators Steve Ellis Tim Henry Nic Chronos David Holmes Bioheart Richard Spencer Howard Leonhardt Doug Owens

    18. MYOHEART US Phase I Study Interim Analysis Pick apart the the attributes of delivery devicesPick apart the the attributes of delivery devices

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