Bioheart Makes Breakthrough in Critical Limb Ischemia Therapy with Stem Cells Obtained from Fat Tissue

SUNRISE, Fla., Dec. 21 /PRNewswire-FirstCall/ --

www.bioheartinc.com

The Bioheart adipose derived stem cells treatment "ASCs Treatment":

  • A large quantity of stem cells can be obtained from a patient's fat (adipose) tissue without pain and other side effects, quickly and cheaply.
  • Adipose stem cells are capable of promoting blood vessel formation and assisting with the healing of damaged blood vessels.
  • Lower limb ischemia is pain, often severe enough to be intolerable, in the lower limb due to limited or inefficient blood circulation.
  • Diabetic patients, globally, are fifteen times more susceptible to limb amputation as a result of lower limb ischemia than other patients. These patients can now be treated using the new therapy.

Bioheart, Inc. (OTC Bulletin Board: BHRT) offers yet another medical breakthrough with the next-level stem cell treatment for critical limb ischemia patients. The stem cells aid in promoting angiogenesis or the formation of new blood vessels and providing support for the healing of damaged blood vessels.

Bioheart, in collaboration with University Hospital Ostrava in the Czech Republic, has already begun treating patients with critical limb ischemia utilizing ASCs. Bioheart is working to place the TGI systems throughout the Czech Republic for a variety of other indications including acute myocardial infarction and chronic heart ischemia, developing new and special treatment plans for patients with these heart issues.

Dr. Karl Groth, Bioheart's Chairman and CEO commented on the therapy: "Stem cell therapy is not just intended as a temporary solution, but it is developed as a novel therapy allowing natural repair of diseased vessels and tissues by using the patient's own cells. Bioheart's TGI system is able to be used in a number of cardiovascular treatments to aid in the recovery of a normal life. That is Bioheart's goal."

"The University Hospital Ostrava is extremely excited to be a part of this cutting-edge technology and welcomes the studies,'' said Dr. Vaclav Prochazka, MD, PhD, MSc, Head Physician of the Department of Interventional Neuroradiology and Angiology, Vice Director for Research and Development at University Hospital Ostrava, Czech Republic, who has been utilizing the cells for treating his patients. "We believe that this will bring new hope to many patients suffering from critical limb ischemia."

Recent studies have identified adipose tissue as an alternate source of stem cells. The procedure for getting adipose derived stem cells from the patient is simple and easily tolerable by the patient even immediately following a heart attack. Fat tissue, itself, is plentiful within the patient's own body and there is an abundance of stem cells within fat tissue. The stem cells can be separated from the fat cells very quickly with the TGI system, making treatment after an event, like a heart attack, efficient. That efficiency contributes to the success of the treatment.

In contrast, the alternative procedure is to use bone marrow to obtain stem cells, which is extremely painful and often yields a low volume of stem cells.

Bioheart is adding the lower limb ischemia treatment to its product portfolio, which seeks to eliminate cardiovascular problems through regeneration and prevention.

Bioheart's TGI 1200 System:

It is a fully-automated, point-of-care system that recovers potentially regenerative stem cells from a patient's own adipose tissue in about an hour, with minimal operator intervention. Adipose tissue is collected from the patient's abdomen and processed in the TGI 1200 System which separates out and collects adipose stem cells.

The CE mark approved system which is distributed by Bioheart under an exclusive license from Tissue Genesis, Inc., accepts adipose tissue from the same device used for liposuctioning the tissue from the patient. The compact desktop unit readily fits into any clinical environment and uses preconfigured disposables for quick and easy operation.

Editor's notes:

ABOUT BIOHEART, INC

Bioheart, Inc. 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.

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, 2008, as amended by its Annual Report on Form 10-K/A, and its Quarterly Reports on Form 10-Q for the quarters ended June 30, 2009 and March 31, 2009.


    Contact:
             Karl E. Groth, Ph.D., Chairman and Chief Executive Officer
             (954) 835-1500

SOURCE Bioheart, Inc.



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