Bioheart Announces Commercial Order for TGI 1200(tm) Adult Stem Cell Isolation System for Use in Chronic Limb Ischemia Patients


SUNRISE, Fla., Jan. 14, 2009 (GLOBE NEWSWIRE) -- Bioheart, Inc. (Nasdaq:BHRT) announced today it has received a purchase order for a TGI 1200 System from Philadelphia BioMed Product Development Centre.*

Bioheart's TGI 1200 System is a fully-automated, point-of-care system that recovers potentially regenerative cells from a patient's own fat in about an hour, with minimal operator intervention. No tissue pre-processing is required. The system, distributed by Bioheart under an exclusive license from Tissue Genesis, Inc., accepts adipose (fat) 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 assembly.

The unit will be kept by Philadelphia BioMed at the University of Jordan's Cell Therapy Centre, under the direction and supervision of Dr. Abdallah Al-Abbadi, MD, who is Professor of Hematology at the Faculty of Medicine, for use by vascular surgeons in chronic limb ischemia patients to improve blood circulation of the limbs and prevent leg amputation. Peripheral vascular disease commonly affects the arteries supplying the leg and is mostly caused by atherosclerosis. Further reduction in blood flow causes ischemic pain at rest, which affects the foot leading to ulceration and gangrene.

Adipose tissue will be collected from the patient's abdomen and processed in the TGI 1200 System to collect the adipose stem cells (ASCs). It is believed that the use of ASCs for treatment of chronic limb ischemia will arrest and possibly reverse the effects of chronic limb ischemia.

Bioheart met last month to discuss this project with the research teams at the University of Jordan, including Dr. Abdelkareem Al-Qudah, the Vice President for Research and Development at the University of Jordan.

"The University of Jordan is extremely excited to be a part of this cutting-edge technology and welcomes advanced clinical studies," said Dr. Moaath Mousa Al-Samady, MD, a vascular surgeon who will be utilizing the cells for treating his patients. "We and the cardiovascular surgeons believe that this will bring new hope to many patients suffering from chronic limb ischemia as well as diseases related to cardiac dysfunction."

Bioheart recently completed another pre-clinical study in collaboration with the University of Jordan under the leadership of Mahmoud Abu-Abeeleh, MD, assistant professor of Cardiac Surgery, University of Jordan School of Medicine, utilizing human ASCs to treat myocardial infarction in rats in which up to 90 percent reduction in myocardial scar size was observed. Bioheart is expecting to commence human studies for acute myocardial infarction in the near future.

*An entity affiliated with a member of Bioheart's Board of Directors

About Bioheart, Inc.:

Bioheart, Inc. (Nasdaq: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.

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.


            

Contact Data