After reviewing supporting pre-clinical data dating back to 1988 and clinical data from controlled studies which began in early 2000 (nearly 400 patients), a panel of experts strongly endorses moving forward to complete the final phase of clinical trials (MARVEL) to advance muscle stem cell (myoblast) therapy for treating heart failure to mainstream use with FDA approval and CMS reimbursement. The MARVEL II program aims to streamline both screening and follow-up to facilitate enrollment and to enhance safety monitoring.
During the panel discussion, Dr.
Highlights from the call include Dr.
Bioheart's latest Phase II/III MARVEL study has undergone interim analysis and although data are not disclosed due to pending publication confidentiality, the panel of experts has reviewed these data and has unanimously and enthusiastically endorsed moving forward to finish the pivotal studies to bring this product to FDA approval based on their review.
Research by these experts and others has shown that myoblasts may have an advantage over other cell types in treating heart failure as they can survive in low oxygen environments (such as the damaged areas of the heart), they are committed to becoming muscle, and they are the only progenitor cell in the human body that normally develop the ability to contract making them more likely to restore contractile function of the damaged heart.
About Bioheart, Inc.
Bioheart, Inc. 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(R), 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(R) 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.
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
Contact: At the Company: Howard J. Leonhardt, Chief Executive Officer (954) 835-1500
SOURCE Bioheart, Inc.