SUNRISE, Fla., March 25 /PRNewswire/ -- Howard J. Leonhardt, Chairman of the Board and CEO of Bioheart, Inc., and Sara Misselhorn, Representative from the Governor's Office of Tourism Trade and Economic Development, today announced the grand opening of Bioheart, Inc.'s new 6,015-square-foot state- of-the-art biologics research facility in Sunrise (13794 NW 4th Street). Local officials and community leaders including Joseph Scuotto, Deputy Mayor, City of Sunrise; Ben Graber, Vice Mayor, Broward County; and James Tarlton (JT), President/CEO, The Broward Alliance, welcomed Bioheart to Broward County. The laboratory's main focus will be on developing and commercializing biologics to treat heart and cardiovascular diseases, in part, through the innovative use of adult-derived muscle stem cells. The new operation is expected to help spur the creation of many new high-value, high-wage jobs in Florida over the next decade.
"Today's grand opening of the new Bioheart Advanced R&D Laboratory demonstrates Florida's growing leadership as an international hub of biotechnology development," said Governor Jeb Bush. "Our infrastructure in this field is increasing, but we have only begun to tap into the vast potential that the industry holds for Floridians and our economy. Florida's life sciences companies are emerging as a major vehicle for generating new capital investment and new high-tech jobs for our citizens, as well as technologies and cures that will directly benefit Floridians for generations to come."
Bioheart, Inc. has raised over $43 million in paid-in capital to date. Their lead product MyoCell(TM), a cell composition for repairing damaged heart muscle delivered via a needle catheter, has reached Phase II/III randomized studies in Europe and is also being studied at five centers in the U.S.A., including Mount Sinai, Mayo Clinic, Cleveland Clinic, The Minneapolis Heart Institute and the American Cardiovascular Research Institute.
"We are grateful to Governor Bush for helping us to celebrate this Grand Opening. We truly believe that this is a great entrepreneurial state in which to build a bioengineering company, and it is a great place to live and raise a family. The state's universities are helping Bioheart to be a leader in this field. We look forward to creating many more jobs here as our company grows. We are committed to having a major impact on reducing the epidemic of heart failure with our product developments," said Leonhardt.
Bioheart, Inc. was founded by Howard J. Leonhardt in 1999 to focus on developing and commercializing biologics to treat heart and cardiovascular diseases. In the very same building that Bioheart has renovated to create this new laboratory, Mr. Leonhardt and many of the other senior members of Bioheart, Inc. previously developed World Medical Mfg. Corp., which became the world's leading company producing cardiovascular stent grafts for thoracic and aortic aneurysm repair. This firm grew from just two employees to over 400 in the course of just over a decade and sold their products in 60 countries. The firm merged with Arterial Vascular Engineering, Inc. in April of 1998 and was acquired by Medtronic, Inc. in early 1999. The Medtronic TALENT(TM) (Taheri- Leonhardt) stent grafts are among the world's leading stent graft systems and have saved thousands of lives.
Bioheart's Board of Directors include representatives from leading cardiology titans such as Guidant Corporation (whom it was recently announced is being acquired by Johnson & Johnson -- observational seat); St. Jude Medical, the leading heart valve maker in the world; Dr. Doris Taylor, the Medtronic Bakken Professor of Physiology and Medicine Director, Center for Cardiovascular Repair at the University of Minnesota; Tyco International-U.S. Surgical; Carlos DeCespedes, Chairman of the Pharmed Group; William P. Murphy, the original founder and former Chairman & CEO of Cordis Corporation (Florida's most successful cardiology-focused company ever); as well as Richard Spencer, former President of Cordis' Sales and Marketing Division. David Gury, the former Chairman of North American Biologics (NABI) and founding member of BioFlorida, has participated as a consultant to Bioheart, Inc. in board meetings as has Mitch Madique, President of Florida International University and former Hambrecht & Quist Technology Investment Banker; Elliott Hahn, the former CEO of Andrx Pharmaceuticals; Norm Dann, the former VP of Operations at Medtronic; Manny Villafana, the founder of St. Jude Medical, ATS Medical, CPI and CABG Medical; and Robert Lashinski, the co- founder and former VP of R&D of Arterial Vascular Engineering, Inc.
Bioheart's Scientific and Clinical Advisory Board includes a number of local leaders, including Dr. Barry Katzen, Director of the Miami Cardiac and Vascular Institute at Baptist Hospital; Dr. James Margolis, Director of Research at the Miami Heart Institute at Mount Sinai; Dr. Camillo Riccordi from the University of Miami; Dr. Eric Crumpler from Florida International University; Dr. Barry Byrne and Dr. Daniel Pauly from the University of Florida; and Dr. Sergio Pinski, the company's Medical Director, from Weston's Cleveland Clinic of Florida. Bioheart, Inc. is actively engaged in research with most of the above mentioned Florida institutions and has hired most of its staff from Florida universities.
Bioheart's second-generation MyoCell II cell composition technology comprises a nutrient-filled hydrogel developed in collaboration with a team at Florida International University and an SDF-1 protein release method currently being studied at the University of Florida. Animal studies have demonstrated that this improved composition has substantially higher bioretention and engraftment in heart scar tissue than the first-generation product. The SDF-1 protein stimulates stem cell recruitment, cell survival, and new blood vessel formation to feed the newly formed muscle within the scar tissue.
In its clinical trials for the MyoCell(TM) and MyoCath(R) product combination, Bioheart is attempting to prove that $30,000 invested into its patented therapy will result in improved quality and length of life as well as a reduction in cost of care over a five-year period of greater than $400,000 per patient. Data from its randomized clinical trials is scheduled to be presented at next fall's major cardiology meetings in the U.S.A. and Europe. To date, nearly 200 patients have been treated worldwide with myoblast (adult muscle stem cell) therapy by various investigators following the U.S. patents controlled by Bioheart, Inc. Data reports from these trials as well as others may be found at Bioheart's web site at http://www.bioheartinc.com/ .
About Bioheart:
Bioheart, Inc. is sponsoring clinical trials of its MyoCell(TM) myogenic cell composition delivered via the MyoCath(R) catheter for damaged heart muscle repair in the U.S.A. and Europe. Bioheart, Inc. controls the pioneering, earliest and broadest composition patent in the field for myogenic (muscle forming or repairing) cell transplantation dating back to 1992, U.S. patent 5,130,141. Bioheart additionally has co-exclusive rights to U.S. Patent No. 5,972,013, covering a deflecting tip needle catheter. For more information about Bioheart, please visit http://www.bioheartinc.com/ or telephone Mr. Jason Griffeth at 954-835-1500.
Bioheart's early clinical study results and animal study results described are not meant to imply that efficacy or safety has been proven. Controlled randomized studies of statistical significance are required and have not been completed as of this date.
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 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. The actual results, including patent protection, may differ from those described in this press release due to risks and uncertainties that exist in the Company's operations and business environment, including, without limitation, the Company's early stage of product development and limited experience in the development of cell therapies in general.
Bioheart, Inc.CONTACT: Jason Griffeth of Bioheart, Inc., +1-954-835-1500
Web site: http://www.bioheartinc.com/
