SUNRISE, FL--(Marketwired - March 04, 2014) - Bioheart, Inc. (OTCQB: BHRT), a biotechnology company focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of degenerative diseases, released today 6 month data from its phase I ANGEL Trial. Fully funded by Bioheart, the trial is being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute (RMI).
"The six month data has far exceeded our expectations. We were excited to see that patients continued to improve from 3 months to 6 months demonstrating the power of a biological product which can actually remodel tissue and change the course of a disease," said Kristin Comella, Bioheart's Chief Science Officer. This phase I study will provide necessary safety and preliminary efficacy of adipose derived stem cells (AdipoCell™) in patients with congestive heart failure. Endpoints include safety, exercise capacity, quality of life, and ejection fraction at 3 months, 6 months and 12 months.
At the 6 month time point, patients are demonstrating an average improvement in exercise capacity or a six minute walk test of approximately 68 meters as compared to an average improvement of 47 meters at 3 months. Eighty percent of the patients showed an improvement in their exercise capacity from 3 months to 6 months post stem cell injection.
Another end point in the study is ejection fraction (EF) by echocardiogram. At the 3 month time point, 100% of the patients demonstrated either improvement or stayed the same. After 3 months, patients showed an average absolute improvement of 3 percentage points in ejection fraction. The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p = 0.01). The full six month data will be presented at the upcoming Age Management Medicine Group conference in Orlando on April 25th (www.agemed.org).
About Bioheart, Inc.
Bioheart, Inc. is dedicated to advancing the field of regenerative medicine by offering the highest quality technology, cellular treatments and training. Specific to biotechnology, Bioheart, Inc. specializes in the discovery, development and commercialization of autologous cellular therapies that treat a wide variety of degenerative diseases.
Bioheart, Inc. is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry by delivering stem cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions, chronic and acute heart damage, peripheral vascular disease and other issues. Bioheart's goals are to improve a patient's quality of life by regenerating their damaged tissue, when possible, and by reducing health care costs and hospitalizations. Bioheart's 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 www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.
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