SUNRISE, Fla., Nov. 20, 2008 (GLOBE NEWSWIRE) -- Bioheart, Inc. (NasdaqCM:BHRT - News), a company committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and other cardiovascular diseases, today announced that CE mark has been applied to the TGI 1200 System in order to begin marketing the TGI 1200 System in all countries recognizing the CE mark. The TGI 1200 System is a fully automated cell isolation system that recovers potentially regenerative cells from a patient’s own adipose (fat) tissue in about an hour, with minimal operator intervention. The system 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 assembly. The CE marking confirms that the device has met essential health and safety requirements, as well as environmental and consumer protection legislation within Europe. Bioheart expects to deliver five TGI 1200 Systems for its European customers by the end of the year.
``This CE marking of the Tissue Genesis Cell Isolation System marks an important milestone for Bioheart as we transition into a commercial company and we are excited to begin shipping the systems to our customers,’' said Howard J. Leonhardt, Chairman, CEO and CTO of Bioheart. ``The TGI 1200 System is intended to give cardiologists a way to reduce some of the damage caused by heart attacks. We recently completed an animal study with stem cells produced by the TGI 1200 that demonstrated a 40 to 90 percent reduction in myocardial scar size following a heart attack in cell-treated animals compared to the control animals.’'
In December 2006, Bioheart entered into an agreement with Tissue Genesis, Inc. which granted Bioheart the exclusive rights to sell or lease the TGI 1200 System to medical practitioners and related healthcare entities worldwide for treating heart diseases including acute myocardial infarction and heart failure. ``We are committed to manufacturing and delivering systems of the highest quality to our current partners as well as to potential licensees,’' said Anton C. Krucky, president and chief executive officer of Tissue Genesis. ``The application of the CE mark on our cell isolation system is an exciting milestone and presents a tremendous opportunity for Tissue Genesis and Bioheart, as it represents further advancement into the international commercialization of our products and technology.’'
About Bioheart, Inc.
Bioheart, Inc. (NasdaqCM:BHRT - News) 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 http://www.bioheartinc.com.
About Tissue Genesis, Inc.
Tissue Genesis, Inc. (http://www.tissuegenesis.com) is a leader in adipose (fat) derived regenerative medicine solutions to address a wide range of therapeutic needs including vascular, cardiovascular, and other regenerative medical applications. The company expects its technology, expertise and products to isolate autologous adipose derived regenerative cells at the point of care for immediate patient needs. Through its business partners, such as Bioheart, SpineSmith, LP and Vet-Stem, Inc., the company is extending the development and application of its technology and platform products to reach worldwide markets in the potential wide use of cell therapy.
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:
Bioheart, Inc. William Kline, Chief Financial Officer 954-835-1500
RedChip Companies, Inc. Bioheart Investor Relations: Len Hardison 800-733-2447, Ext. 118 info@redchip.com
Bennet Group Media Contact for Tissue Genesis: Lee Tokuhara 808-531-6087, Ext. 105 Cell: 808-295-7329 lee@bennetgroup.com
Source: Bioheart, Inc.
