SUNRISE, Fla., Aug. 26 /PRNewswire-FirstCall/ -- Bioheart, Inc., (OTC Bulletin Board: BHRT) announces that the treatments and 3 month follow up with stem cell therapy on the first two congestive heart failure patients has been performed successfully at Hospital Angeles Tijuana through its Center of Excellence, Regenerative Medicine Institute of Tijuana, Mexico. In March, Bioheart entered into an agreement to establish a Center of Excellence for the introduction of its therapies. Through the program with Bioheart, Regenerative Medicine Institute provides therapies for congestive heart failure (CHF) and peripheral arterial disease (PAD) patients at the Hospital Angeles Tijuana, a fully equipped state-of–the-art private specialties hospital.
The therapy involved the use of stem cells derived from the patient's own fat (adipose tissue) obtained using liposuction. Stem cells were separated from the adipose tissue utilizing the fully-automated TGI Cell Isolation System. The separation process takes about an hour. No tissue pre-processing is required with this system. The recovered stem cells were injected into the patients' hearts with Bioheart's MyoCath® needle injection catheter.
Dr. Juan J. Parcero, the treating Interventional Cardiologist and head of the cardiac program at the Hospital Angeles commented on Bioheart's program, "The ability to offer cutting edge treatments and regenerative medicine has provided new hope to these patients. We are very pleased with the positive outcomes seen in the patients treated so far." Dr. Parcero has led the efforts with this new program with expert team members Drs. Oscar Mendoza and Luis Ruvalcaba, Echo cardiologists, Dr. Silvia Gonzalez, Plastic Surgeon, Dr. Nelson Varas, Anesthesiologist Cardiologist and Dr. Jesus Perez, Hospitalist.
To date, four patients have been treated utilizing the TGI Cell Isolation System. Two of the patients have completed the 3-month follow-up testing. A significant improvement was seen in both the 6-minute walk as well as the left ventricular ejection fraction (LVEF). The first patient improved his walking distance from 315 to 420 meters and LVEF from 32% to 38%. The second patient improved his walking distance from 450 to 492 meters and LVEF from 40% to 55%.
Mike Tomas, Bioheart's President and Chief Executive Officer added, "We are extremely excited about the Center of Excellence established in Mexico and the preliminary results are very promising. We look forward to providing novel therapies and regenerative medicine to additional heart failure patients whose options are currently limited."
About the TGI 1200 Cell Isolation System
The CE-marked TGI 1200 Cell Isolation System is a fully automated and easy-to-use system, which processes liposuctioned fat tissue and delivers isolated regenerative cells in about an hour. The instrument allows for point-of-care recovery of an average of 30 to 40 million regenerative cells per 60cc of a patient's processed fat. These cells can then be used at the site of injury or disease.
About Bioheart, Inc.
Bioheart is committed to maintaining our leading position within the cardiovascular sector of the cell technology industry delivering cell therapies, intelligent devices and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. We work to prevent the worsening of any condition with devices that monitor and diagnose. Our goals are to cause damaged tissue to be regenerated, if possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.
Specific to biotechnology, we are 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. 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.
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Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to obtain additional financing; (ii) our ability to control and reduce our expenses; (iii) our ability to establish a distribution network for and commence distribution of certain products for which we have acquired distribution rights; (iv) our ability to timely and successfully complete our clinical trials; (v) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (vi) the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; (vii) our dependence on the success of our lead product candidate; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; (ix) our ability to protect our intellectual property rights; and (x) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2009, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.
Catherine Sulawske-Guck, Chief Operating Officer
|SOURCE Bioheart, Inc.|
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