SUNRISE, Fla., Feb. 20 /PRNewswire/ -- Bioheart, Inc., a leader in developing cell therapies for heart repair, announced today a patent licensing agreement with Cleveland Clinic of Cleveland, Ohio, to further develop its innovative cell-based technology.
The agreement provides Bioheart, Inc. with the worldwide exclusive rights to five pending U.S. patent applications and corresponding foreign filings related to the repair of scarred heart tissue damaged from a heart attack. The patents pending cover methods of repairing damaged heart tissue by transplanting muscle stem cells that express therapeutic proteins capable of recruiting other stem cells within a patient’s own body to the cell transplanted area. The recruited stem cells further assist in the tissue repair process and help to increase blood vessel formation.
“Adding the Clinic’s proprietary methods to Bioheart’s existing muscle stem cell technologies fits well with our strategy to continuously improve our products,” said Howard J. Leonhardt, Chairman and CEO of Bioheart.
Jay S. Yadav, M.D., Chairman of CCF Innovations, the Clinic’s technology transfer and commercialization arm, said, “This agreement sets the framework for the Clinic and Bioheart to maximize our respective strengths for the development of leading-edge technologies that will have a measurable impact on the state-of-the-art care patients receive.”
The agreement gives Bioheart access to a minimum of three new products to treat myocardial infarction and heart failure along with a first right of refusal to related product improvements. Marc Penn, M.D., Ph.D. of the Departments of Cardiovascular Medicine and Cell Biology at Cleveland Clinic has conducted large animal studies on the first potential product for which Bioheart plans to file an Investigational New Drug application with the Food and Drug Administration (FDA) in order to begin human clinical trials.
“We are excited about this collaboration with Bioheart, Inc. and I look forward to working with their team to move these cell-based technologies forward to the clinic and to the many patients that may potentially benefit from them,” the Clinic’s Dr. Penn said.
Gary Francis, M.D., a cardiologist and congestive heart failure expert at the Clinic and President of the Heart Failure Society of America, agrees. “This agreement will foster further development toward a better understanding of new therapies,” Dr. Francis said. “There is an expectation that patients with heart failure will stand to benefit the most from stem cell therapy, but a refined knowledge of how it works and in whom it works will go a long way toward achieving this important goal.”
About CCF Innovations:
The Cleveland Clinic Foundation’s strong commitment to discovery and innovation led to the establishment of CCF Innovations (CCFI) in 2000. CCF Innovations commercializes all inventions and related technology from throughout The Cleveland Clinic. The Clinic’s comprehensive commercialization approach includes prototyping, seed and technology validation funds, clinical trials, translational research cores, animal facilities, on-site accelerator, entrepreneurs-in-residence, allied venture capital fund, expert staff, venture advisors, start-up mentoring programs, selective in-licensing and ideation labs. Fifteen companies have been spun-off from the Cleveland Clinic in the last four years.
About the Cleveland Clinic:
Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Approximately 1,500 full-time salaried physicians at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2004, patients came for treatment from every state and 100 countries. Cleveland Clinic’s website address is http://www.clevelandclinic.org .
About Bioheart:
Bioheart, Inc., founded in June 1999, develops myogenic cell technology for repairing damaged heart muscle first developed by a number of scientists in 1988. The company began sponsoring clinical trials of this technology in 2001 and has advanced to Phase II/III randomized clinical trials with its MyoCell(TM) cell composition and MyoCath(R) delivery catheter for repairing damaged heart muscle. The company holds rights to over 50 related patents and patents pending. To date approximately 250 patients have been treated worldwide following these cell composition patents at over 30 centers including The Cleveland Clinic. Over 25 million people worldwide have been diagnosed with heart failure and this number is expected to double over the next decade. Class III heart failure patients, the main target group being studied at this time for this new therapy, currently face an annual mortality rate of 12 to 20% with previously available therapy choices. Class IV heart failure patients also included in some of the current studies face a 50% annual mortality rate with currently available treatments. Bioheart, Inc. believes its therapy is the first non-surgical method being studied in Phase II/III clinical trials to potentially provide recovery of damaged or weakened myocardial tissue; other therapies primarily attempt to get un-damaged portions of the heart to pump more efficiently.
Bioheart, Inc. is sponsoring clinical trials of its MyoCell(TM) myogenic cell composition delivered via the MyoCath(R) catheter for damaged heart muscle repair at 10 sites in Europe and 5 in the USA. For more information about Bioheart, please visit http://www.bioheartinc.com or telephone Mr. Jason Griffeth at 954-835-1500.
Statements in this press release that are not strictly historical may be “forward-looking” statements, which involve risks and uncertainties. There can be no assurance that Bioheart, Inc. will be able to commercially develop cardiovascular cell therapy or electrical stimulation products, that necessary regulatory approvals will be obtained or that any clinical trials will be successful or that the proposed treatments will prove to be safe and/or effective.
Bioheart, Inc.
CONTACT: Jason Griffeth, Bioheart, Inc., +1-954-835-1500
