SUNRISE, Fla., May 6, 2011 (GLOBE NEWSWIRE) -- Bioheart, Inc. (OTCBB:BHRTE) today announced it is one of the presenters at the upcoming World Stem Cells and Regenerative Medicine Congress in London from May 9th – 11th. The three day conference will feature a hybrid of business, regulatory and scientific topics, with speakers drawn from pharmaceutical and biotech companies, the regulators and cell and gene therapy developers.
Kristin Comella, Bioheart's Chief Scientific Officer, will be presenting Bioheart's products for treating heart failure including MyoCell, Bioheart's combined cell therapy product approved by the FDA for a phase II/III trial. This session will discuss the Bioheart experience in taking cell therapy products to the clinic and the challenges of ensuring patient safety while on the path to commercialization. The MARVEL Trial, begun in 2007, is a randomized, double-blind, placebo-controlled, multi-center trial involving 150 patients in North America across 35 different centers such as Minneapolis Heart, Mayo Clinic, the Cleveland Clinic and Columbia University. Bioheart is hoping to compound upon the positive research compiled during part 1 of the Phase II/III trial in which MyoCell treated patients improved 91.7 meters in exercise capacity while placebo injected patients declined 4 meters. The company hopes to capitalize by providing a better quality of life for the more than 25 million people who suffer from heart failure today.
About Bioheart, Inc:
Bioheart, Inc., founded in 1999, seeks to be the "go to technology partner for heart failure specialists and their patients". The company's flagship product MyoCell is an adult muscle stem cell composition, also known as immature myoblasts, derived and processed from patient's own thigh muscle. These cells are delivered to a patient's heart via the MyoCath needle tipped catheter or a similar device which is inserted through the patient's groin and is directed to the inside of the heart where the injections are made. MyoCell has been in clinical trials for treating advanced heart failure patients since early 2001. A 2nd generation composition MyoCell SDF-1 received FDA approval for clinical trials. This composition is made up of genetically modified cells that over express the stromal derived factor 1 protein that has been shown to improve blood vessel formation and muscle development. Bioheart, Inc. has also initiated clinical evaluation of methods of treating heart ischemia, acute myocardial infarctions and lower limb ischemia utilizing adipose (fat) derived cells. Bioheart is focused on heart failure and has a building pipeline of product developments to assist care providers in treating and caring for these patients.
Forward-Looking Statements:
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 March 31st, 2011.
CONTACT: Bioheart, Inc. Catherine Sulawske Guck, Chief Operating Officer 954 835 1500, email csguck@bioheartinc.com