Bioheart Inc. (BHRT) has breakout day over FDA OK

Posted on: Wednesday, September 14th, 2011
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Bioheart Inc. (OTCBB: BHRT) leaped 15.3% to 8.3 cents Wednesday on word of a clinical program the company was engaging in, using adipose cells. Volume for the stock topped 8.1 million near Wednesday’s close.

A news release issued Sept. 14 declared that the company out of Sunrise, Florida announced that they will begin a U.S. 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 Food and Drug Administration (FDA) to begin a Phase I study in the US.

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 six-minute walk distance.

The U.S. 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 was quoted in the same release as saying, “Safety and efficacy have been successfully demonstrated in the trial at Hospital Angeles and we are looking forward to beginning one of the first U.S. trials using adipose derived cells for congestive heart failure patients.”

Bioheart is committed to maintaining our leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.

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Category: Healthcare, OTCBB
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