SUNRISE, Fla., April 14 /PRNewswire-FirstCall/ -- Bioheart, Inc. announced that treatment with stem cell therapy on two congestive heart failure (CHF) patients was performed successfully at the Hospital Angeles Tijuana, Mexico, through Bioheart's Center of Excellence program with Regenerative Medicine Institute.
Dr. Karl Groth, Bioheart's Chairman and Chief Executive Officer explained, "These procedures validate Bioheart's innovation of effective treatments for the most serious cardiac health issues confronting people around the world. Our mandate is to bring Bioheart's solutions wherever they are needed and can be utilized."
In March, Bioheart entered into the first of its five planned agreements in Latin America to establish Centers of Excellence for the introduction of its therapies. The Regenerative Medicine Institute of Tijuana, Mexico is the first of these programs and provides therapies for congestive heart failure and peripheral arterial disease (PAD) patients at the Hospital Angeles Tijuana, a fully equipped state-of-the-art private specialties hospital.
About Bioheart's program enabling treatment to be conducted in Centers outside the US, Dr. Sherman says, "I have come to believe that valuable knowledge can be gained from small-to-moderate sized clinical studies conducted outside of the US. Depending on objectives and design, the costs and logistics of certain studies can be burdensome, or even prohibitive to conduct in the US. The two key points here are, first and foremost, to ensure the rights and safety of patients, wherever a clinical trial is done. And secondly, that data arising from the study be complete and transparent. Without both elements in-place, a study will unlikely add to our knowledge of stem cell repair, or advance the field. To my eyes, Bioheart's initiative ensures that the integrity of both treatment and data collection is preserved, and I anticipate the scientific community will eagerly follow the program's progress."
Anton Krucky, CEO of Tissue Genesis, commented on Bioheart's successes with the use of the TGI system: "We are excited about the momentum that Bioheart is gaining in the use of Tissue Genesis' methods and technologies. Their recent successes in Europe and South America give us a great deal of confidence in Bioheart's ability to deliver cardiovascular regenerative medicine services to the Americas."
Dr. Javier Lopez, Regenerative Medicine Institute's President, stated: "It is valuable to be able to help those in our country who are suffering from congestive heart failure and other cardiovascular problems that can be resolved with Bioheart's therapies and enables our Institute to be in the forefront of treatment centers around the world."
About the TGI 1200 Cell Isolation System
The CE-marked TGI 1200 Cell Isolation System is a fully automated and simple system, which processes liposuctioned fat tissue and delivers isolated regenerative cells in about an hour. The compact desktop unit requires no tissue pre-processing, and fits easily into any clinical environment. The instrument allows for point-of-care recovery of an average of 50 million regenerative cells per 60cc of a patient's processed fat. These cells can then be used at the site of injury or disease. Regenerative cells may amplify the body's own repair process, accelerate healing, repair damaged and diseased tissue, and prevent scarring and loss of function.
About Bioheart, Inc
Bioheart is committed to maintaining a 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. The Company works to prevent the worsening of any condition employing devices that monitor and diagnose. Bioheart's expertise is regenerating damaged tissue, if possible, and improving a patient's quality of life in addition to reducing health care costs and hospitalizations.
For more information on Bioheart, visit www.bioheartinc.com.
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.
CONTACT: Karl E. Groth, Ph.D., Chairman and Chief Executive Officer,
+1-954-835-1500, kgroth@bioheartinc.com
Web site: http://www.bioheartinc.com/