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Bioheart (OTC: BHRT; Twitter: $BHRT)
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6. Myoblast Engraftment Post-Transplantation Contractile muscle tissue growing in the scarred portion of the heart following treatment with myoblast injections. Human Heart, Proof of Concept * Hagege et al., Viability and Differentiation of Autologous Skeletal Myoblast Grafts in Ischemic Cardiomyopathy, Lancet, Vol. 361, 2003: 491-492
7. MyoCell: Heart Failure Treatment Process Scar tissue following heart attack Injection of skeletal myoblasts into scar tissue using deflecting-tip catheter Cell manufacturing following thigh muscle biopsy 1 3 2
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9. Journal of the American College of Cardiology, Vol. 42, No. 12, 2003, Serruys, Smits et al. Study sponsored by Bioheart, Inc. LVEF Measured via LAO LV Angio. 3 month, p=0.009; 6 month, p=0.23. N = 5. Percutaneous Intramyocardial Transplantation of Autologous Myoblasts: Bioheart First-In-Man Experience LVEF (%)
10. Percutaneous Intramyocardial Transplantation of Autologous Myoblasts – BIOHEART Phase I/II Trial Results for these trials were not statistically significant due, in part, to the limited number of patients treated. Baseline 6 Months 12 Months N = 13 N = 13 N = 13 LVEF: Mean Baseline = 34.4% + 7.4 Mean 12-Month Follow-up = 36.6% + 9.6 NYHA Class Improvement
11. Measurements via PV Loop, n=5. 33 41 190 150 4.6 5.6 Percutaneous Intramyocardial Transplantation of Autologous Myoblasts – BIOHEART Phase I/II Trial LVEF CO LVESV
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13. * All 5 treated patients withdrew due to changes in German biopsy regulations. ** Both control patients withdrew after knowledge of randomization allocation. Bioheart Percutaneously Delivered Myoblasts EU Phase II Trial (SEISMIC) 47 Patients Randomized: ICD Patients: 31 MyoCell ® , 16 Standard Medical Therapy Treatment Arm ( MyoCell ® 150 - 800 x 10 6 ) 26 ICD Patients Control Arm (Standard Medical Therapy) 14 ICD Patients Baseline Evaluation Screening: 62 ICD Patients 15 Screen Fails 5 Withdrawals* 2 Withdrawals**
14. SEISMIC NYHA heart failure class Improvement Myoblast therapy Control therapy N=26 N=23 N=22 N=20 N=14 N=9 N=12 N=13 BL 1 mo 3 mo 6 mo BL 1 mo 3 mo 6 mo
15. SEISMIC +60.3 m + 54.1 -0.2 m ± 177.1 Treatment N=26 N=21 N=19 Control Control N=14 N=12 N=13 448 m 441 m 406 m 466 m 6-Minute Walk Test Improvement Difference Between Baseline and 6 Months
17. MYOHEART US Phase I Study Flow Clinical Sites: Columbia Presbyterian, Cleveland Clinic, Mayo Clinic, Minneapolis Heart, St. Joseph ’ s / ACRI Core 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 Safety Evaluation Second Cohort (n=5) 75 x 10 6 cells 30 - Day Safety Evaluation Third Cohort (n=5) 225 x 10 6 cells 30 - Day Safety Evaluation Fourth Cohort (n=5) 675 x 10 6 cells 27 injections (.50 cc)
18. MYOHEART 6MWT Average 6 Minute Walk Test – All Cohorts 6MWT (meters) N=20 422 474 471 N=18 N=15 47 36 N=15 6MWT (meters) N=18 All Patients Paired Analysis p = .0074 p = .2126 474 N=17 42 p = .1367 N=17
19. MYOHEART MLHFQ Average Minnesota Living with Heart Failure Score All Cohorts MLHF Score N=20 51 34 33 N=19 N=18 -14 -16 N=19 N=18 All Patients Paired Analysis p = .0016 p = .0004 MLHF Score 30 N=18 N=18 -18 p = .0006
26. Myoblast – Cell culture Process Development Manufacturing process is protected, scalable and reliable
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30. Bioheart: The FDA Approved REGEN Trial Next Generation: MyoCell ® SDF-1 Increased muscle formation Increased blood vessel supply Endogenous circulating stem cells attracted to injury by chemokine proteins Damaged area secretes chemokine proteins Adult stem cells SDF-1 Cells Four years of sponsored animal studies have demonstrated that 2nd generation MyoCell ® SDF-1 provides significantly higher levels of improvement than the first generation MyoCell ® composition.
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Notes de l'éditeur
Used Bioheart cells with MyoStar / Noga system No patient deaths or SAEs reported 1 patient was hospitalized at 6 weeks after the procedure due to progressive heart failure and long asymptomatic runs of non-sustained VT on Holter monitoring. After recompensation, telemetry still showed NSVT, and an ICD was placed prophylactically. Other 4 patients experienced no AEs or ventricular arrhythmias.
Summary of data from FIM, 005-006 trials. Data adjudicated by Cardialysis (CRO, Rotterdam, the Netherlands) and Cleveland Clinic (independent core lab)
Note dose is patient and infarct size dependent.
5 sites: Mayo Clinic, Cleveland Clinic, Mt. Sinai (NYC), Minneapolis Heart, ACRI / St. Joseph ’s (Atlanta) Interim data expected at TCT in October 2005.
Mean Values Left graph represents all data available at each time point Right graph is paired analysis – i.e. matched data from BL to 3 mos. and BL to 6 mos. for only those patients available at these timepoints Trends for all patients treated from BL through 6-Months look compelling and are partially statistically significant Consistent with p-values to what Dr. Dib saw in his study (n=23) P values computed using paired t test
Median Values Left graph represents all data available at each time point Right graph is paired analysis – i.e. matched data from BL to 3 mos. and BL to 6 mos. for only those patients available at these timepoints Statistical significance attained at both 3 and 6 months Consistent with p-values to what Dr. Dib saw in his study (n=23) P values computed using paired t test