SUNRISE, Fla., March 17 /PRNewswire-FirstCall/ -- Bioheart, Inc. a biotechnology company that is focused on the development of autologous (patient-derived) cell therapies and devices for the treatment of chronic and acute heart damage, today announced that it has been awarded U.S. Patent #: 7341062 (J. Chachques and H. Leonhardt) for a method to repair damaged myocardium (heart tissue) by a combination of cell transplantation and electrostimulation. The award of this patent brings to more than 100 the number of related patents and patents pending to which the company holds rights.
The patent covers methods for repairing damaged heart tissue by providing electrostimulation to patient-derived myogenic cells either in the laboratory while the cells are expanding or after the cells are implanted into the damaged areas of the patient's heart. One potential application for this technology that Bioheart is exploring is to adapt a bi-ventricular pacemaker with a separate lead that could apply the electrostimulation to the cell-transplanted regions. Electrostimulation induces the cells to contract in an even more synchronized basis with the surrounding tissue and increase their ability to release growth factors and other beneficial proteins. This patent is complimentary to Bioheart's previously granted patent for inducing angiogenesis by electrical stimulation, based on research conducted by Dr. Shinichi Kanno and Dr. Yasufumi Sato(1). Another application for this technology may be to combine it with Bioheart's MyoCell(R) therapy for the recovery of heart muscle in cardiac patients afflicted with damaged heart tissue.
"We are pleased with the awarding of this patent to Bioheart," said William M. Pinon, president and chief executive officer of Bioheart. "We believe that this procedure could one day be a cost-effective solution to improve patient outcomes and enhance the quality of life for cardiac patients worldwide."
About the Heart Failure Market
Heart failure is associated with significant morbidity, high incidence of complications, frequent hospitalization and rising healthcare costs. In the United States alone, an estimated 5 million individuals have a diagnosis of "congestive heart failure," and an additional 500,000 new cases are diagnosed annually.
About MyoCell(R)
Bioheart's lead product candidate, MyoCell, is an innovative clinical cell therapy designed to populate regions of scar tissue within a patient's heart with living muscle tissue for the purpose of improving cardiac function in chronic heart failure patients. MyoCell uses adult stem cells that are precursors to muscle cells, or myoblasts, which are derived from the patient's own body. When injected into scar tissue within the heart wall, myoblasts have shown to be capable of engrafting in the damaged tissue and differentiating into mature muscle cells. The core technology used in MyoCell has been the subject of human clinical trials conducted over the last seven years and animal studies conducted over the last twenty years. Our most recent clinical trials of MyoCell include the SEISMIC Trial, a 40-patient Phase II clinical trial in various countries in Europe and the MYOHEART Trial, a completed 20-patient Phase I dose escalation trial in the United States. Final results of the MYOHEART Trial were announced in January 2008. The FDA recently cleared us to proceed with a multicenter Phase II/III trial for MyoCell in the United States, named the MARVEL Trial, which will enroll up to 330 patients.
About Bioheart, Inc.
Bioheart, Inc. is a biotechnology company focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell, is an innovative clinical cell therapy designed to populate regions of scar tissue within a patient's heart with autologous muscle cells, or cells from the patient's body, for the purpose of improving cardiac function in chronic heart failure patients. The company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose cell treatment for acute heart damage, and MyoCell II with SDF-1(TM), a therapy utilizing autologous cells genetically modified to express additional growth factors. The company holds rights to more than 100 related patents and patents pending.
(1) Circulation. 1999; 99:2682-2687
MyoCell and MyoCell II with SDF-1 are registered trademarks of Bioheart, Inc.
Forward-Looking Statements:
Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
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 secure additional financing; (ii) the timely success and completion of our clinical trials; (iii) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (iv) regulatory approval of our product candidates; (v) our dependence on the success of our lead product candidate; (vi) our inability to predict the extent of our future losses or if or when we will become profitable; (vii) our ability to protect our intellectual property rights; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; and (ix) intense competition . The company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including Post-Effective Amendment No. 5 to its Registration Statement on Form S-1 (Registration No. 333-140672) filed on February 13, 2008.
Contact: William Kline Lytham Partners, LLC Chief Financial Officer Joe Diaz Nicholas Burke Joe Dorame Vice President-Financial Operations Robert Blum (954) 835-1500 (602) 889-9700
