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

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, including digital imaging and standard quality of life measurement such as the six-minute walking test, New York Heart Association (NYHA) heart failure classification and Minnesota Living with Heart (MLHF) questionnaire. Final six-month results observed in the SEISMIC Trial include:
-- 84 percent of treated patients experienced improved or unchanged

six-minute walking test scores compared to 16 percent of the control

group

- 69 percent of the control group's results worsened, versus only

16 percent of the treated group

-- 94 percent of treated patients experienced improved or unchanged NYHA

classification compared to 58 percent of the control group

- 42 percent of the control group's results worsened, versus only

6 percent of the treated group

Prof. Serruys also noted that reports of arrhythmia among the patients evaluated in SEISMIC, both in terms of total number of episodes as well as timing of episodes, were no different between the treatment and control arms in the study. This suggests that MyoCell is not associated with a higher prevalence of arrhythmias; rather, that arrhythmias are an expected occurrence for this subset of heart failure patients.

"These data support the need for a randomized, double-blind, placebo-controlled study involving the MyoCell technology," said Prof. Serruys. "We look forward to applying our learning from this trial to the larger, more comprehensive MARVEL(2) Trial currently underway in the U.S. and Europe."

The MARVEL Trial, a randomized, double-blind, placebo-controlled, multi-center Phase II/III Trial involving 330 pati
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SOURCE Bioheart, Inc.
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