SUNRISE, Fla., April 1 /PRNewswire-FirstCall/ -- Bioheart, Inc., (OTC Bulletin Board: BHRT) announced today that Howard Leonhardt, Bioheart's Chief Scientific and Technology Officer, converted a loan he had made to Bioheart and the loan's related interest, constituting together over $2 million, into restricted common shares and warrants through Bioheart's PIPE ("Private Investment in Public Equity"). Mr. Leonhardt is also Bioheart's founder and former chairman.
Mr. Leonhardt stated, "Today I am increasing my investment stake in Bioheart by $2 million due to my great confidence in the future of the company. I feel that Bioheart's current stock price does not reflect its potential. The strides that the Company has made to deliver its products to the world are great, and, greater still, are those products themselves. Once those therapies receive FDA approval in the US, I am sure that Bioheart's cardiovascular treatments will be seen generally as expanding the frontiers of medicine, and Bioheart will come to be viewed by the world as an incredible investment. While my loan to Bioheart carried an attractive yield, my return on investment, now that the conversion to equity has taken place, will, in my view, far exceed any interest I would have earned."
Mr. Leonhardt is an entrepreneur and, in addition to his other positions with the Company, chairs, along with Dr. Doris Taylor, Bioheart's Scientific Advisory Board. Serving on that Board are the world's leaders in the realms of cell technology, interventional cardiology, and research into both regenerative medicine and cardiovascular disease. Before founding Bioheart, in 1986, he founded World Medical Manufacturing Corporation, and served as its Chief Executive Officer from 1986 until December 1998, when World Medical was acquired by Arterial Vascular Engineering, Inc., or AVE. In turn, AVE was acquired by Medtronic, Inc. in January 1999. Mr. Leonhardt was the co-inventor of World Medical's primary product, the TALENT (Taheri-Leonhardt) stent graft system. From December 1998, until June 1999, Mr. Leonhardt remained with Medtronic, serving as President of World Medical Manufacturing Corporation.
Mr. Leonhardt also serves on the board of the non-profit, Cell Therapy Foundation, and its affiliated Adult Stem Cell Research Network.
Bioheart's PIPE is an investment vehicle whose participants must meet the SEC's definition of accredited investors and enables the purchase of specially priced units consisting of restricted common shares and warrants. Five others connected with Bioheart have increased their stakes significantly in the Company in recent weeks.
Bioheart recently announced the commencement of its FDA-approved Phase I REGEN trial, the first trial of a combined cell and gene therapy. The therapy employs MyoCell, a muscle-derived cell treatment designed to populate regions of scar tissue within a patient's heart with new living cells, along with SDF-1, for the purpose of improving cardiac function in chronic heart failure patients.
The Company's TGI system for obtaining stem cells from adipose (fat) tissue is currently being used in several countries to treat lower limb ischemia, chronic heart ischemia, and will soon be used for other indications.
Two weeks ago, the company also announced a program to offer treatment for cardiovascular disease using its therapies in five Centers of Excellence in Latin America, beginning with the Tijuana-based Hospital Angeles Tijuana, a fully equipped and state-of–the art private specialties hospital, through Regenerative Medicine Institute.
Commenting on Bioheart's lead product, MyoCell, Mr. Leonhardt said: "Last fall, we presented the interim results from our Phase II/III randomized double-blinded placebo controlled clinical trial, the MARVEL trial, at the annual Heart Failure Society of America meeting. The treated patients improved an average of 91.7 meters in their six minute walk distance. Thus, our MyoCell patients improved 95.7 meters over the placebo patients. The placebo patients were even on optimal drugs. The current gold standard for treating heart failure, bi-ventricular pacing, achieved only a 16 to 20 meter improvement over placebo in trials."
About Bioheart, Inc
Bioheart is a leader position within the cardiovascular sector of the cell technology industry delivering cell therapies, intelligent devices and biologics that address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. The company works to prevent the worsening of any of these conditions with devices that monitor and diagnose cardiac illness. The company's therapeutic objectives are to regenerate damaged tissue, to improve a patient's quality of life, and to 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 and peripheral vascular disease. 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, 2009.
At the Company:
Karl E. Groth, Ph.D., Chairman and Chief Executive Officer
(954) 835-1500; www.bioheartinc.com
SOURCE Bioheart, Inc.