SUNRISE, Fla., April 1 /PRNewswire-FirstCall/ -- Bioheart, Inc., 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 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.
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.
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.
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.”
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.
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.
Bioheart, Inc.