SUNRISE, Fla., March 30 /PRNewswire-FirstCall/ -- Bioheart, Inc., (OTC Bulletin Board: BHRT) announced today that Dr. Karl E. Groth, the Company's Chairman and CEO will speak at the 2010 Translational Regenerative Medicine Forum in Winston-Salem, North Carolina, on April 8. Dr. Groth will discuss Bioheart's cell therapies for Congestive Heart Failure. Bioheart's therapies, which are currently in trials all over the world, aim to bring to patients, who otherwise would have little hope for a normal life, cutting edge therapies using as a basis, cells taken from their own fat or muscle tissue.
The Conference is sponsored by the Regenerative Medicine Foundation, a not-for-profit organization created to advance new treatments and therapies based on tissue engineering and regenerative medicine. The Foundation believes that integrating life science and engineering disciplines will bring new clinical approaches to patients for the treatment of diseases affecting a wide range of tissues and organs.
By fostering collaboration between public and private initiatives, the Foundation capitalizes on the academic, industry and governmental resources in regenerative medicine and expedites the pace of research so that innovative therapies are developed and delivered to patients more rapidly. The Regenerative Medicine Foundation has been designed to be the connection point for a variety of interests, with education and interdisciplinary collaboration serving as the core and sustaining values of the organization.
The Conference focuses on best practices in clinical trials and GMP facilities, as well providing a forum to discuss regulatory and reimbursement challenges. In addition, the conference features a venture forum to introduce early-stage and later-stage companies to accredited and institutional investors.
Bioheart has recently announced plans for establishing five Centers of Excellence in Latin America to provide its cell therapy procedures to patients suffering from congestive heart failure (CHF) and peripheral arterial disease (PAD) beginning next month, April 2010. In addition, Bioheart is conducting the first combined gene and cell therapy Phase I study approved by the FDA, the REGEN trial for MyoCell combined with SDF-1. Bioheart has also begun a Phase II/III double-blinded study of its MyoCell product, the MARVEL trial, designed to obtain approval from the FDA for that product, and released in September of 2009 preliminary results of that study. The study showed 35% improvement among treated patients in six-minute walk time, a result considered to be remarkable.
Dr. Karl Groth, Bioheart's Chairman and Chief Executive Officer said, "Making cell therapies available globally to patients suffering from cardiovascular disease is our goal. We feel that our cell therapies have proven the capability to regenerate heart tissue and feel that our therapies constitute superior solutions for the resolution of heart failure issues. We want to turn around the adverse impact on people's lives that CHF and PAD have created."
About Heart Failure
Heart failure is a debilitating condition. When heart failure is in an advanced state, the heart is unable to pump enough blood to the body to allow a person to enjoy a normal, productive life. This disease affects over 5 million people in the United States. Over 500,000 new cases are diagnosed annually in the U.S., making heart failure the most rapidly growing of all cardiovascular disorders. According to statistics provided by the American Heart Association, the approximate direct and indirect annual cost of heart failure treatment in the U.S. is $22.5 billion. Persons over the age of 65 experience heart failure as the number one cause of hospitalization and the number one cause of death.
About Bioheart, Inc
Bioheart is committed to maintaining our leading position within the cardiovascular sector of the cell technology industry delivering cell therapies, intelligent devices and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. We work to prevent the worsening of any condition with devices that monitor and diagnose. Our goals are to cause damaged tissue to be regenerated, if possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.
Specific to biotechnology, we are focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. MyoCell is a clinical muscle-derived 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.
Bioheart has licensed from Tissue Genesis Inc. for cardiovascular use the CE-marked TGI 1200 Cell Isolation System is a fully automated and easy-to-use system, which processes liposuctioned fat tissue and delivers isolated regenerative cells in about an hour. The compact desktop unit requires no tissue pre-processing, and fits easily into any clinical environment. The instrument allows for point-of-care recovery of an average of 30 to 40 million regenerative cells per 60cc of a patient's processed fat. These cells can then be used at the site of injury or disease. Regenerative cells may amplify the body's own repair process, accelerate healing, repair damaged and diseased tissue, and prevent scarring and loss of function.
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 December 31, 2008, as amended by its Annual Report on Form 10-K/A, and its Quarterly Reports on Form 10-Q for the quarters ended September 30, June 30, 2009 and March 31, 2009.
At the Company:
Karl E. Groth, Ph.D., Chairman and Chief Executive Officer
SOURCE Bioheart, Inc.