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Final Data From the Bioheart Seismic Trial Suggest Safety, Efficacy of Autologous Stem-Cell Therapy for Treating Congestive Heart Failure
Date:4/1/2008

ents in North America and Europe, is the largest trial of its kind to date. Enrollment in the MARVEL Trial began in October 2007, targeting patients who fall into Class II or III heart failure. The MARVEL Trial will further study the safety and efficacy of the minimally invasive MyoCell autologous stem-cell therapy in the treatment of congestive heart failure delivered via a MyoStar(TM) injection catheter(3), in combination with the NOGA(R) XP Cardiac Navigation System. The Principal Investigator for the MARVEL Trial is Warren Sherman, MD, Director, Cardiac Cell-based Endovascular Therapies, Columbia University Medical Center, New York.

ABOUT MYOCELL CLINICAL CELL THERAPY

MyoCell clinical cell therapy, developed by Bioheart, Inc., is currently being studied as an investigational product in Europe and the U.S. MyoCell clinical cell therapy is intended to be used to improve cardiac function months or even years after a patient has suffered severe heart damage due to a heart attack. The procedure involves a physician removing a small amount of muscle obtained from the patient's thigh. From this muscle specimen, autologous myoblasts (muscle stem cells) are then isolated, grown using Bioheart's proprietary cell-culturing process, and injected directly into the scar tissue of the patient's heart. The myoblast cells are delivered via an endoventricular needle-injection catheter during a minimally invasive procedure performed by an interventional cardiologist or vascular surgeon. The myoblast-based muscle formation in the newly populated regions of scar tissue are intended to improve cardiac function by helping the heart muscle beat more efficiently.

ABOUT HEART DISEASE

Approximately nine million European patients and 5.2 million Americans(4) suffer from congestive heart failure, a progressively degenerative condition in which the heart is unable to adequately pump blood throughout the body resulting in fluid accumulation in the lungs, kidneys, a
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SOURCE Bioheart, Inc.
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