SUNRISE, Fla., Jan. 13, 2009 (GLOBE NEWSWIRE) -- Bioheart, Inc. (Nasdaq:BHRT) announced today it has filed with appropriate agencies in Switzerland for reimbursement approval for its MyoCell(r) myogenic cell therapy for heart failure. Bioheart has approval to treat patients with MyoCell cell therapy at the Kantonsspital Luzern (Hospital in Luzern, Switzerland) with Prof. Paul Erne as the principal investigator. This patented composition and method has been studied in clinical trials involving more than 350 patients to date at over 100 centers worldwide since the year 2000. Data from one of these trials conducted by Bioheart indicates that about 84 percent of the myogenic stem cell treated patients improve in quality of life and exercise capacity. In comparison, in trials involving control patients, only 31 percent of patients on heart failure drugs improved.
Bioheart, through its European contract manufacturer, was previously awarded a manufacturing permit from the Netherlands Ministry of Health for the in vitro culture of autologous myoblasts for use as human medications. The filing submitted relates to obtaining reimbursement approval for a specific heart failure related indication of use. The initial reimbursement application filings are targeting the sickest Class III and IV heart failure patients who have not responded well to drugs and do not qualify for a bi-ventricular pacemaker. It is estimated that approximately 250,000 of the 9 million European patients in heart failure will qualify for this initial indication of use. Bioheart is applying for a reimbursement level matching exactly that charged to provide bi-ventricular pacemakers for this same patient population. In clinical studies, bi-ventricular pacemakers have demonstrated a 16 to 20 meter improvement in 6-minute walking distance over control treatment; whereas, in Bioheart's MyoCell studies, the results have been 55 to 90 meters improvement in 6-minute walking distance compared to control.
About Bioheart, Inc.:
Bioheart, Inc. (Nasdaq:BHRT) is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is 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 muscle-derived stem 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. The Company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart, visit www.bioheartinc.com.
MyoCell and MyoCell SDF-1 are 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 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, 2007, as amended by Amendment No. 1 on Form 10-K/A and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2008, June 30, 2008 and September 30, 2008.