Shawshank, VA 9/19/2011 (PennyPayDay) – Bioheart, Inc. (OTC:BHRT) Friday announced, in a press release, it is one of the presenters at the upcoming Cell Therapy Commercialization Summit in Boston from September 19th -- 21st. The three day conference will deliver a comprehensive tool kit for taking your cell therapy product from pre-clinical to commercialization.
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 and LipiCell, Bioheart's adipose derived stem cells. Bioheart is one of only eight companies that have been chosen to present as part of the investor forum on the 19th. In addition, Bioheart will present on the importance of clinical trial design and how to avoid costly errors and loss of time.
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. 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.
Bioheart is focused on completing the Phase II/III MARVEL study for chronic heart failure using MyoCell. The product candidate has been in clinical trials since May of 2001 with the goal of commercial approval with the current clinical program. There are approximately 130 more patients needed to complete the randomized, double blinded, placebo controlled MARVEL trial. In part one of the MARVEL trial, the performance of MyoCell was nearly 500% above its primary end point goal of 16 meters improvement in exercise capacity testing. MyoCell treated patients improved 91.7 meters while placebo patients declined 4 meters.
MyoCell is a muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the intended purpose of improving cardiac function and quality of life in chronic heart failure patients.
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