Healthcare Industry News:  Critical Limb Ischemia 

Regenerative Medicine Wound Care

 News Release - January 10, 2011

Bioheart Reports Positive Results for Adipose Derived Stem Cells in Critical Limb Ischemia

SUNRISE, Fla., Jan. 10, 2011 -- (Healthcare Sales & Marketing Network) -- Bioheart, Inc. (OTCBB:BHRT ) announced positive efficacy data has been reported from the registry study of bone marrow and adipose derived stem cells for the treatment of end stage Critical Limb Ischemia with wounds. Vaclav Prochazka MD, PhD, MSc., of University Hospital Ostrava, Czech Republic presented data at the American Academy of Anti-Aging Medicine Conference in Las Vegas last month.

"We are very pleased with the preliminary results of adipose derived cells. This is a continuation of our research of bone marrow derived stem cells. Our results have been published this month in Cell Transplantation," said Dr. Prochazka.

The study focuses on end stage patients with severe wounds. Endpoints include elimination of major amputation risk, ankle brachial index, toe pressure, transcutaneous oxygen pressure, and quality of life. Dr. Prochazka presented results of a clinical study with bone marrow derived cells and preliminary follow up of the adipose registry study. Seventy-five percent of patients presented with healing and pain reduction while only twenty-five percent of the patients required major limb amputation due to disease progression. Autologous adult bone marrow derived stem cells (BMSCs) and adipose tissue derived stem cells (ADSCs) can help to produce angiogenesis or formation of new blood vessels as well as assist in the healing process. There were no reported deaths or severe adverse events demonstrating the safety of the products.

Mike Tomas, President and CEO of Bioheart stated, "We are very excited to offer new hope to patients with Critical Limb Ischemia. Being able to prevent amputation in 75% of these patients demonstrates the true healing effect of adipose derived stem cells."

About Bioheart, Inc:

Bioheart, Inc. founded in 1999 seeks to be the "go to technology partner for heart failure specialists and their patients." The company's flagship product MyoCell is an adult muscle stem cell composition, also known as immature myoblasts, derived and processed from a patient's own thigh muscle. These cells are delivered to a patient's heart via the MyoCath needle tipped catheter or a similar device which is inserted through the patient's groin and is directed to the inside of the heart where the injections are made. MyoCell has been in clinical trials for treating advanced heart failure patients since early 2001. A 2nd generation composition MyoCell SDF-1 received FDA approval for clinical trials. This composition is made up of genetically modified cells that over express the stromal derived factor 1 protein that has been shown to improve blood vessel formation and muscle development. Bioheart, Inc. has also initiated clinical evaluation of methods of treating heart ischemia, acute myocardial infarctions and lower limb ischemia utilizing adipose (fat) derived cells. Bioheart is focused on heart failure and has a building pipeline of product developments to assist care providers in treating and caring for these patients.

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, 2009, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2010.

Source: Bioheart

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