Bioheart (OTC:BHRT) to Begin Clinical Trials

Northern, WI 9/15/2011 (PennyPayDay) – Bioheart, Inc. (OTC:BHRT) announced yesterday, in a press release, that they will begin a US clinical program called the ANGEL trial utilizing adipose derived cells or LipiCell for congestive heart failure patients. Using the clinical data from a Phase I/II trial in Mexico and preclinical studies, Bioheart will apply to the FDA to begin a Phase I study in the US. BHRT is also under a pretty aggressive e-mail promotion campaign initiated recently by a third party investor.

In collaboration with the Regenerative Medicine Institute of Tijuana, Mexico, six congestive heart failure patients have been successfully treated in a Phase I/II trial at Hospital Angeles Tijuana. The therapy involves the use of stem cells derived from the patient's own fat (adipose tissue) obtained using liposuction. These patients have demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance.

The US ANGEL trial design and results from the Mexico trial were presented by Bioheart's Chief Scientific Officer, Kristin Comella at the Stem Cells USA & Regenerative Medicine Congress in Boston this week. She stated, "Safety and efficacy have been successfully demonstrated in the trial at Hospital Angeles and we are looking forward to beginning one of the first US trials using adipose derived cells for congestive heart failure patients."

Bioheart has completed several preclinical studies demonstrating the safety and efficacy of this product including a study led by Keith March, MD, PhD, Director of the Vascular and Cardiac Center for Adult Stem Cell Therapy at the Indiana University. The adipose cells showed a tendency toward cardiomyocyte regeneration, prominent angiogenesis (growth of new blood vessels) and reduction in the infarction size.

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