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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

ject to its timely receipt of additional financing and barring any unforeseen changes.

This study has a cell concentration of up to 200 million cells/ml and administers 16 injections per patient, with varying dosing per injection. There are three study groups in the trial, one receiving a total of 800 million cells, one receiving a total of 400 million cells and the third receiving placebo injections. In contrast, previous studies involving MyoCell(R) Therapy had a cell concentration of 50 million cells/ml and administered 32 injections per patient. Animal studies involving MyoCell(R) therapy have suggested increased cell retention, survival and engraftment with the higher concentration of cells and lower number of injections, in part due to lower inflammation response.

"We expect the MARVEL Trial will confirm our current beliefs regarding the safety and efficacy of MyoCell," said Howard J. Leonhardt, CEO and Chief Technology Officer, Bioheart. "Results from our completed Phase I US MYOHEART Trial and Phase II European SEISMIC Trial showed 83-94 percent of the MyoCell(R) treated heart failure patients improved, or did not worsen, in Quality of Life or heart failure class while only 6-17 percent worsened. In comparison, in the SEISMIC Trial control group, 58 percent of the patients that received drugs only improved or did not worsen while 42 percent of such patients worsened.

In October, Bioheart intends to apply for approval to market and reimbursement for MYOCELL(R) Therapy in various countries in Europe for the sickest Class III heart failure patients that continue to deteriorate despite treatment with all currently available therapies applied including drugs, pacers and mechanical assist devices, with no additional therapeutic options.

ABOUT CONGESTIVE HEART FAILURE

Congestive heart failure (CHF), or heart failure, is a condition in which the heart cannot pump enough oxygenated blood to the body's vital organs. People with heart
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SOURCE Bioheart, Inc.
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