Bioheart, Inc.'s Appeals to the FDA for Compassionate Use Designation to Save Lives
Published: Mar 27, 2013
SUNRISE, FL--(Marketwire - March 27, 2013) - Bioheart, Inc. (OTCQB: BHRT) today announced that the Company is preparing to request of the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) permission to allow access to investigational drugs outside of a clinical trial setting. Bioheart's cell therapy products address an unmet need in the cardiac market by providing true regenerative medicine where the MyoCell® product line may regenerate muscle in areas of scar tissue and the LipiCell® product may help reduce inflammation and promote the growth of new blood vessels.
Expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial.
"We decided to initiate this program as we have had a continuing large number of requests by physicians and patients to make MyoCell® and LipiCell® available on a compassionate basis," said Mike Tomas President/CEO of Bioheart. "Preliminary analysis of interim data results from our cardiac products and centers of excellence suggests that we can safely provide MyoCell® and LipiCell® for treatment of selected cardiac patients, and that the agent has potential to benefit some of these patients. Knowing this information, we believe the ethical choice is to make the drug available on a compassionate use basis."
Information about the Company's clinical trials can be found at the NIH registry, www.clinicaltrials.gov. Interested parties are encouraged to visit Biohearts' website, http://www.bioheartinc.com, where details on the compassionate use program and additional information will be posted in the near future.
About Bioheart, Inc.
Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and 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 and peripheral vascular disease. Its 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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