SUNRISE, Fla., Feb. 3, 2009 (GLOBE NEWSWIRE) -- Bioheart, Inc., (Nasdaq:BHRT) today announced it has arranged with its local partner, Biomedica, in Italy, for a complete grant-supported study of the Bioheart A&C Bio Science T-PLS(r) Twin-Pulsatile Life Support System, a blood pump that is introduced through small percutaneous punctures into the femoral artery and femoral vein of a patient. The first shipments were made this week to a hospital in Italy, and testing on the system should be completed within 45 days. If the test results are positive, sales forecast for the systems in Italy alone for 2009 will be approximately 35 units at $60,000 each, for a total contract value estimated at $2,100,000.
The CE Marked Bioheart A&C Bio Science T-PLS has been used in more than 300 patients to date with success. The T-PLS may be used to provide percutaneous quick perfusion following an Acute MI (heart attack) to reduce scar size in combination with the coronary infusion of endothelial progenitor cells and stem cells from Bioheart's CE Mark approved TGI-1200 system. It may also be used following a stroke to reduce brain damage or as a standard heart lung by-pass machine during cardiac surgery. The A&C Bio Science team is working on a new improved model which includes a blood cooling system.
A&C Bio Science, Inc. has also partnered with Bioheart to develop a significantly lower-cost Left Ventricle Assist Device -- the Bioheart A&C Bio Science SVAD -- which is currently in the last stages of pre-clinical studies and preparing for clinical studies. Bioheart has requested A&C Bio Science co-develop a percutaneous catheter placeable implantable LV-filling pressure sensor and an LV heart pump on a catheter.
About A&C Bio Science, Inc.
A&C Bio Science, Inc. is a Korean incorporated company whose Ordinary Shares are listed on the Korea Exchange and whose main country of operation is Korea. The Company has two operating divisions, the artificial organs division that designs, manufactures and distributes artificial human organs such as kidney dialysis and artificial combined heart and lung machines and the digital division that designs, manufactures and distributes certain consumer electronic device. The Company also has a 70 percent owned subsidiary, Bioheart Manufacturing Inc. (BHM), through which it operates its human cell therapy business and shareholdings in two other companies, and Bioheart Florida, LLC (together with the "Company," the "Group"). Bioheart, Inc. has an 18 percent ownership stake in Bioheart Manufacturing Inc.
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.
MyoCell, MyoCell SDF-1 and MyoCath are trademarks of Bioheart, Inc.
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.