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Final Data From the SEISMIC Trial Suggest Safety, Efficacy of Autologous Stem- Cell Therapy for Treating Congestive Heart Failure
Date:4/1/2008

Leading Expert Discusses Study During Late-Breaking Presentations at ACC

CHICAGO, April 1, 2008 /PRNewswire/ -- Final six-month, follow-up patient data presented today during the late-breaking clinical trial sessions at the American College of Cardiology, suggest MyoCell(R) myoblast clinical cell therapy is a safe and potentially effective alternative treatment to standard medical therapy alone for improving heart function among patients with previously implanted cardiac devices who are experiencing congestive heart failure.

The findings from the SEISMIC(1) Trial, a 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe, evaluated MyoCell myoblast clinical cell therapy delivered via the MyoCath(R), endoventricular needle-injection catheter in patients previously fitted with implanted cardiac defibrillators(ICDs), receiving standard medical therapy and who are experiencing congestive heart failure. On admission to the trial, patients were randomized on a two-to-one ratio into the treatment versus control groups with 26 patients receiving MyoCell therapy and 14 patients in the control group. All patients were experiencing congestive heart failure and were previously fitted with ICDs and receiving standard medical therapy. Both the MyoCell biologic therapy and the MyoCath needle-injection catheter, developed by Bioheart, Inc., are currently being studied as investigational products.

"The results from the SEISMIC Trial are encouraging," said Prof. Patrick W. Serruys, MD, PhD, Principal Investigator and Chief, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center - Rotterdam, the Netherlands. "While the study was specifically designed to show safety, the findings also suggest positive trends in clinical benefits when evaluating the treated group versus the control group at six months."

Patients in both groups were evaluated at three- and six-month intervals using a variety of tests, i
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SOURCE Bioheart, Inc.
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