Bioheart's MyoCell Recognized as one of the Breakthrough Developments of 2010
SUNRISE, Fla., Aug. 30 /PRNewswire/ -- Bioheart, Inc. - (OTC Bulletin Board: BHRT) The mission of the Cell Therapy Foundation is to improve public health through the support of effective adult stem cell research and education. The Foundation aims to promote basic and applied knowledge, processes and cell therapies. As part of this mission Cell Therapy Foundation provides updates concerning advances in adult stem cell research. A recent initiative tabulating clinical trials involving cell therapy identified Bioheart's MyoCell as one of only a few cell therapies that are presently in the Phase III stage of clinical trials in the United States. MyoCell has shown the ability to improve heart function in patients suffering from heart failure.
At the Heart Failure Society of America Annual Meeting, Bioheart presented interim results from their randomized, double blinded, placebo controlled Phase II/III clinical trial called MARVEL. The MARVEL study focused on treating significant scar tissue damage caused from a previous heart attack in advanced heart failure patients. The results were outstanding. MyoCell treated patients improved 91.7 meters in the six minute walk test, while the placebo patients declined 4 meters.
Dr. Warren Sherman, Lead Investigator of the MARVEL trial and Director of Stem Cell Research and Regenerative Medicine at Columbia University Medical Center stated, "The early positive clinical results from Bioheart's MyoCell are truly an example of how far along adult stem cell research has come. We are very close to proving the value of adult stem cell therapy for a major unmet indication such as heart failure. This is very exciting to all of us in the field."
Bioheart's MyoCell is a composition of immature myoblasts or adult muscle stem cells derived from a biopsy of a patient's thigh muscle. This muscle biopsy is sent to Bioheart's cGMP laboratory where the muscle stem cells are isolated and expanded. The cells are delivered directly into the scar tissue of the heart using Bioheart's MyoCath, a deflecting tip needle catheter. These stem cells may form contractile muscle in the scar tissue of damaged hearts.
Howard J. Leonhardt, Founder of Bioheart, Inc., Chief Scientific and Technology Officer as well as Chairman of their Scientific Advisory Board added, "The Bioheart investigators and our internal team are truly honored by this recognition from the Cell Therapy Foundation. Only our cell type has demonstrated an ability to form contractile muscle in scar tissue, which differentiates our clinical trial from all others."
The Cell Therapy Foundation is a premier source for the advancement of adult stem cell awareness, acceleration and development of useful research and therapies which will result in the global improvement of public health. Emerging as a leader in raising funds for adult stem cell research, Cell Therapy Foundation strives to increase awareness about adult stem cells, to fund disease-specific adult stem cell research, and to accelerate the rate of clinical trials. www.celltherapyfoundation.org
About Bioheart, Inc.
Bioheart is committed to maintaining a leading position within the cardiovascular sector of the cell technology industry, delivering cell therapies, intelligent devices and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. We work to prevent the worsening of any condition with devices that monitor and diagnose. Our goals are to enable 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. 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 www.bioheartinc.com.
Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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.
Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to obtain additional financing; (ii) our ability to control and reduce our expenses; (iii) our ability to establish a distribution network for and commence distribution of certain products for which we have acquired distribution rights; (iv) our ability to timely and successfully complete our clinical trials; (v) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (vi) the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; (vii) our dependence on the success of our lead product candidate; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; (ix) our ability to protect our intellectual property rights; and (x) intense competition. The Company is also 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, 2009, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010.
Catherine Sulawske Guck, Chief Operating Officer
954 835 1500
SOURCE Bioheart, Inc.
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