SUNRISE, Fla., March 12, 2009 (GLOBE NEWSWIRE) -- Bioheart, Inc. (Pink Sheets:BHRT) announced today that Dr. Michael Brown and Mrs. Judy Brown, research consultants, have rejoined Bioheart's clinical team to provide increased support to its clinical trials. Dr. Brown previously served as Bioheart's Chief Scientific Officer and Vice President of Clinical Affairs from 1999 to 2004 and as a consulting Senior Clinical Specialist from January 2005 to December 2006. Prior to that, he was a clinical specialist at Medtronic, Inc. Judy Brown was previously Director of Clinical Research at World Medical Manufacturing Corporation from May 1998 to August 2000 and served as a consultant for World Medical in 2001. Prior to this work, she coordinated clinical trials at the Baptist Cardiac & Vascular Institute, Miami, from 1990 to 1997. Her prior experience was in basic science research at the University of Miami, where the two met. They have 40 years of combined basic science and clinical research management experience between them.
The Browns, a husband and wife team, will focus on monitoring the safety of Bioheart's clinical trials, assembling data and writing reports for regulatory agencies. Their work will include periodically updating Bioheart's Summaries of Safety and Efficacy. In this work, they join Bioheart's lead heart-failure clinical trials consultant, Dr. Chris O'Conner, Director of Duke University's Heart Failure Program; and Bioheart's Medical Director overseeing the trials, Dr. Sergio Pinski, Head of Cardiac Pacing and Electrophysiology Section, Heart Failure and Arrhythmia Clinic, Cleveland Clinic Florida. Bioheart is committed to providing "World Class" safety monitoring in its trials.
The Browns will work closely with Bioheart's independent Data Safety Monitoring Boards and Bioheart's 35-member Clinical and Scientific Advisory Board. A full listing of Bioheart's Clinical and Scientific Advisory Board is available at the company's Web site: http://www.bioheartinc.com/sab.php.
Bioheart, Inc. is currently sponsoring a Phase II/III clinical trial at 35 sites in the United States for its MyoCell(r) muscle stem cell composition for treating advanced heart failure. Since 2000, over 350 patients have been enrolled in various clinical trials involving muscle stem cells for treating heart failure. The company foresees the beginning of a dose escalation clinical trial in the U.S. for MyoCell(r) SDF-1, its second-generation cell composition for treating heart failure that was developed in collaboration with the Cleveland Clinic and the University of Florida.
Other clinical studies being initiated include lower limb ischemia, heart ischemia and acute MI trials for the CE Mark approved Bioheart TGI 1200(tm) system for processing adipose tissue, providing stem cells and endothelial progenitor cells bedside within an hour. The company is also in the process of initiating additional studies for its products which have FDA authorization and are already commercially available on the market in the U.S such as the Bioheart 3370 At-Home Heart Failure Monitoring System and the Bioheart-Monebo Cardiobelt(r).
Bioheart is committed to being the "Go To" technology partner for heart failure specialists and their patients. The world population of heart failure patients is expected to grow from 25 million patients today to over 50 million in the next 5 years. With previously available technologies, 50 percent of the people diagnosed with advanced heart failure are expected to die within 3 to 5 years of diagnosis. Bioheart is passionately committed to improving the outcomes and quality of life of these patients.
About Bioheart, Inc.
Bioheart, Inc. (Pink Sheets: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(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.
MyoCell, MyoCell SDF-1 and MyoCath 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.