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Bioheart Announces 35 Leading U.S. Heart Failure Centers Engaged in Phase II/III Marvel Trial of Myogenic Cells for Treating Advanced Heart Failure
Date:9/30/2008

Company Targeting to Complete Enrollment of 150 patients by March 2009

SUNRISE, Fla., Sept. 30 /PRNewswire-FirstCall/ -- Bioheart, Inc., (Nasdaq: BHRT), today announced that 35 of the leading U.S. Heart Failure Centers have engaged in Bioheart's Phase II/III MARVEL(1) Trial of myogenic cells for treating advanced heart failure.

"With 35 leading heart failure centers engaged, we are making tremendous progress in patient screening and enrollment," said Dr. Warren Sherman, Principal Investigator and Director, Cardiac Cell-based Endovascular Therapies, Columbia University Medical Center, New York. "We have added nearly 45 patients into our trial in the past three months."

The MARVEL Trial, a randomized, double-blind, placebo-controlled, multi-center Phase II/III Trial involving 330 patients in North America and Europe, is the largest trial of its kind to date. Enrollment in the MARVEL Trial began in October 2007, targeting patients who fall into Class II or III heart failure. The MARVEL Trial is studying the safety and efficacy of MyoCell autologous clinical cell therapy in the treatment of congestive heart failure delivered via a MyoStar(TM) injection catheter(2), in combination with the NOGA(R) XP Cardiac Navigation System. The MyoCell injection process is a minimally invasive procedure which presents less risk and considerably less trauma to a patient than conventional (open) heart surgery.

The trial is designed for an interim look at 150 patients with six-month follow-up. Based on the statistical significance of these interim results, the Company will explore the potential to submit for early commercial approval in the United States. Bioheart is on track to complete enrollment of 150 patients by March 2009, sub
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SOURCE Bioheart, Inc.
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