SUNRISE, Fla., March 23 Bioheart, Inc., (OTC Bulletin Board: BHRT) announced today plans for establishing five Centers of Excellence in Latin America to provide its cell therapy procedures to patients suffering from congestive heart failure (CHF) and peripheral arterial disease (PAD) beginning next month, April 2010. Bioheart entered into its first agreement with a leading treatment facilitator, Regenerative Medicine Institute of Tijuana, Mexico. Therapies for CHF and PAD patients will be made available at the Hospital Angeles Tijuana, a fully equipped state-of-the-art private specialties hospital. This will be the first of five Centers of Excellence with four additional Centers to be announced in the coming months.
Dr. Karl Groth, Bioheart's Chairman and Chief Executive Officer added, "Making cell therapies available globally to patients suffering from cardiovascular disease is our goal. Our first step was taken more than 10 years ago, when Bioheart was established. This relationship with Regenerative Medicine Institute and Hospital Angeles Tijuana brings both our organizations closer to providing global access to cardiovascular regeneration."
Warren Sherman, M.D., of Columbia University Medical Center's Stem Cell Research Institute, Chris O'Conner, M.D., and Tom Povsic, M.D., Ph.D., of Duke University's Clinical Research Institute, have, with Bioheart, established an Academic Advisory Committee to monitor these Centers of Excellence and gather data on the results seen by each Center. These results will, over time, become a compendium and form a nexus for future cell therapy research.
"We are adding Bioheart's stem cell therapies to the treatments available to our patients, as we have determined from our investigations into stem cell therapy, that these cell therapies are safe and that these therapies may enable our patients to live normal lives. Most of our doctors were trained in the U.S. and are comfortable having access to beneficial and cutting edge technologies. We are committed to bringing to our Hospital Angeles Tijuana patients such therapies," said Dr. Javier Lopez, President of Regenerative Medicine Institute.
Bioheart's therapy for CHF and PAD utilizes stem cells derived from the patient's own fat (adipose tissue) through liposuction. Stem cells are then separated from the adipose tissue with the fully-automated TGI 1200 Cell Isolation System in about an hour. The recovered stem cells are injected into the heart with Bioheart's MyoCath catheter. No tissue pre-processing is required.
The MyoCath was developed by Bioheart co-founder Robert Lashinski specifically for delivering new cells to damaged tissue. It is a deflecting tip needle injection catheter that has a larger needle which is 25 gauge for better flow rates and less leakage than systems that are 27 gauge. This larger needle allows for thicker compositions to be injected which helps with cell retention in the heart. Also, the MyoCath needle has more fluoroscopic brightness than the normally used nitinol needle, enabling superior visualization during the procedure. Seeing the needle well during injections enables the physician who is operating the catheter to pinpoint targeted areas more precisely, thus improving safety. The MyoCath competes well with other biological delivery systems on price and efficiency and allows the physician to utilize standard fluoroscopy and echo equipment found in every cath lab.
Howard Leonhardt, Bioheart's Founder and Chief Scientific and Technology Officer, assessing the MyoCath's use in clinical trials stated: "The MyoCath was the primary catheter utilized in Bioheart's Phase I study for the US FDA completed at the Mayo Clinic, Minneapolis Heart Institute, Atlanta Cardiovascular Research Institute and Columbia University Medical Center. It was also the primary catheter used in Bioheart's Phase II study led by Professor Patrick Serruys in Europe. Physicians feel that the MyoCath provides superior flexibility along with precision when compared to the alternatives."
Stuart K. Williams, Ph.D., of the University of Louisville and Chief Scientific Officer of Tissue Genesis, Inc., commenting on the MyoCath: "The MyoCath brings an incredible amount of technology to the delivery of cells through an intravascular route to the damaged area of the heart. This is not a trivial problem, and I am impressed with Bioheart's technology in this field. The major attribute of the MyoCath technology is its simple design and implementation. I have seen some incredibly complex technology necessitating a long learning curve before utilization, resulting in significant potential problems. It's all about placement, reproducibility and precision. The MyoCath development team has done a fantastic job."
Recent studies have identified adipose tissue as an alternate source of stem cells. The procedure for obtaining adipose derived stem cells from the patient is a relatively simple process and tolerated by most patients even immediately following a heart attack. Fat tissue can usually be found in abundance within the patient's own body and has a greater number of stem cells than bone marrow. The TGI 1200 system can isolate stem cells in about an hour, allowing for immediate clinical, point-of-care treatment after an event like a heart attack, which is important to the effectiveness of the treatment. In contrast, the procedure for obtaining stem cells from bone marrow can be painful and often yields a low volume of stem cells.
In addition to offering treatment for congestive heart failure with the TGI system, Regenerative Medicine Institute will be using the TGI 1200 system to treat lower limb ischemia using a similar process. The TGI 1200 Cell Isolation System is currently being utilized in clinical studies to treat chronic heart ischemia in Venezuela and critical limb ischemia in the Czech Republic.
The final step for incorporating Bioheart therapies into its system will be making available MyoCell, Bioheart's muscle stem cell therapy for CHF. 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.
Bioheart's Phase II European SEISMIC study demonstrated that 94% of patients treated with MyoCell, improved or did not worsen while only 6% deteriorated. Improvement or status quo in 6 minute walk distance was seen in 84% of treated patients, while only 16% saw a reduction. In those patients treated with a placebo, 42% saw deterioration in their Heart Failure class and 69% saw a reduction in distance with their 6 minute walk. Bioheart's system produced commensurate heart function improvement in treated patients.
About the TGI 1200 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 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 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. 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 Heart Failure
Heart failure is a debilitating condition. When heart failure is in an advanced state, the heart is unable to pump enough blood to the body to allow a person to enjoy a normal, productive life. This disease affects over 5 million people in the United States. Over 500,000 new cases are diagnosed annually in the U.S., making heart failure the most rapidly growing of all cardiovascular disorders. According to statistics provided by the American Heart Association, the approximate direct and indirect annual cost of heart failure treatment in the U.S. is $22.5 billion. Persons over the age of 65 experience heart failure as the number one cause of hospitalization and the number one cause of death.
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, 2008, as amended by its Annual Report on Form 10-K/A, and its Quarterly Reports on Form 10-Q for the quarters ended September 30, June 30, 2009 and March 31, 2009.
Contact: At the Company: Karl E. Groth, Ph.D., Chairman and Chief Executive Officer (954) 835-1500
SOURCE Bioheart, Inc.