Bioheart Files With the FDA to Begin the ANGEL Trial

Tue Dec 6, 2011 5:00am EST

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SUNRISE, Fla., Dec. 6, 2011 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced that they have completed an Investigational New Drug (IND) application to the FDA for the ANGEL trial. The clinical protocol is designed to assess the safety and cardiovascular effects of intramyocardial implantation of autologous adipose derived stem cells (LipiCell) in patients with chronic ischemic cardiomyopathy. Transplantation of LipiCell will be accomplished through endocardial implantations with the MyoStar™ Injection Catheter under the guidance of the NOGA® cardiac navigation system by Biosense Webster, Inc. – A Johnson & Johnson Company. 

The IND submission included results from an ongoing Phase I/II trial in Mexico. Bioheart in collaboration with the Regenerative Medicine Institute has successfully treated nine heart failure patients using LipiCell. 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.

Bioheart's Chief Scientific Officer, Kristin Comella stated, "We are looking forward to being one of the first companies to bring these therapies to US trials. We have successfully demonstrated the safety and efficacy of adipose cells in preclinical studies as well as our clinical trial in Mexico." 

About Bioheart, Inc.

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. Our goals are to cause damaged tissue to be regenerated, if possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, we are focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Our leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.

For more information on Bioheart, visit http://www.bioheartinc.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2010, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.

CONTACT: Bioheart, Inc.
         Catherine Sulawsk-Guck
         Chief Operating Officer
         954-835-1500
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