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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

ncluding 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 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 will further study the safety and efficacy of the minimally invasive MyoCell autologous stem-cell th
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SOURCE Bioheart, Inc.
Copyright©2008 PR Newswire.
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