Profile: Bioheart Inc (BHRT.PK)
18 Sep 2014
Bioheart, Inc., incorporated in August 1999, is a development-stage, biotechnology company. The Company focuses on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. 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. The Company’s clinical trials of MyoCell include the SEISMIC Trial, which completed a 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe; the MYOHEART Trial, a completed 20-patient, multicenter, Phase I dose-escalation trial conducted in the United States, and the MARVEL Trial, a 330-patient, multicenter Phase II/III trial of MyoCell in North America and Europe.
As part of the MyoCell therapy, a general surgeon removes approximately 5 to 10 grams of thigh muscle tissue from the patient utilizing local anesthesia, typically on an outpatient basis. The muscle tissue is then express-shipped to a cell culturing site. At the cell culturing site, its techniques are used to isolate and remove myoblasts from the muscle tissue. It typically produces enough cells to treat a patient within approximately 21 days of his or her biopsy. After the cells are subjected to a variety of tests, the cultured cells are packaged in injectate media and express shipped to the interventional cardiologist. Within four days of packaging, the cultured myoblasts are injected via catheter directly into the scar tissue of the patient’s heart. The injection process takes on average about one hour and can be performed with or without general anesthesia. Following treatment, patients generally remain in the hospital for approximately 48-72 hours for monitoring. The MyoCath is a deflecting tip needle injection catheter for delivering new cells to damaged cardiac tissue in therapeutic procedures to treat chronic heart ischemic and congestive heart failure tissue.
The Company competes with Medtronic, Inc., Acorn Cardiovascular, Inc., St. Jude Medical, Inc., World Heart Corporation, Guidant Corporation, Edwards Lifesciences Corp., Pfizer’s, Aldagen, Inc., Angioblast Systems, Inc., Athersys, Inc., Baxter International, Inc., Cytori Therapeutics, Inc., MG Biotherapeutics, LLC, Mytogen, Inc., Osiris Therapeutics, Inc. and ViaCell, Inc.
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