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United States FDA Clears the REGEN Trial to Test Bioheart's Combination Gene and Stem Cell Therapy in Heart Failure Patients
Date:7/28/2009

dge, this will be the first clinical trial ever to test a combination gene and stem cell therapy for cardiovascular disease."

The U.S. trial is expected to begin this year. After completing the REGEN safety protocol with one-month follow-up, the company hopes to transition this second-generation product into its FDA-authorized Phase II/III MARVEL study. MyoCell SDF-1 is substantially similar to the original MyoCell composition that has been active in clinical trials since early 2001 at more than 50 centers worldwide.

The patents Bioheart has acquired covering the myogenic cells and SDF-1 compositions and methods are expected to provide intellectual property protection until 2023.

About Bioheart, Inc.

Bioheart, Inc. is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell((R)), is an innovative clinical muscle-derived stem 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. The Company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell((R)) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart, visit

SOURCE Bioheart, Inc.
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