BioSphere Medical's HepaSphere(TM) Microspheres to Be Featured at CIRSE 2006 Conference.
HepaSphere Microspheres ("HepaSphere") are CE Marked, denoting conformity with European standards for safety and allowing for marketing in European Union countries. BioSphere is currently selling HepaSphere through its direct sales force in France and its network of distributors in the remaining countries of the European Union. HepaSphere has also been used in clinical evaluation in Japan since 1992.
Richard Faleschini, president and chief executive officer of BioSphere Medical, commented, "We are encouraged by the performance so far of HepaSphere following its introduction to the European medical community at last year's CIRSE meeting. We believe that the availability of HepaSphere in Europe has provided physicians with an important new avenue to use embolotherapy to treat primary and metastatic liver cancer. Based on our observations to date, we also believe that HepaSphere may improve patient outcomes by enabling physicians to deliver targeted, customized treatment."
Gary Saxton, BioSphere Medical's executive vice president and chief operating officer, commented, "HepaSphere's unique set of properties are designed to increase the effectiveness of embolization. The product's spherical shape allows for a predictable, targeted occlusion. HepaSphere rapidly absorbs aqueous-based solutions such as contrast media and saline, expanding to four times its dry state diameter. The embolic conforms to the vessel architecture, resulting in a high degree of contact with the vessel wall and complete vessel occlusion."
Mr. Faleschini also noted that preliminary data from the multi-site CIRSE Foundation UFE Registry will be presented at the 2006 CIRSE Annual Meeting. The purpose of the registry, which is co-sponsored by BioSphere, is to collect and analyze procedure and patient data submitted by European physicians who perform uterine fibroid embolization (UFE).
BioSphere has filed a 510(k) premarket notification with the U.S. Food and Drug Administration seeking marketing clearance for QuadraSphere(TM) Microspheres ("QuadraSphere") for the treatment of hypervascularized tumors and peripheral arteriovenous malformations. QuadraSphere is technically identical to HepaSphere; however, the 510(k) application for QuadraSphere does not include specific indications for use in treating primary and metastatic liver cancer. FDA approval to promote the use of QuadraSphere in treating primary and metastatic liver cancer will require separate clinical trials in the United States. Because QuadraSphere has not been cleared by the FDA, this product is not currently available for sale in the United States.
CIRSE provides continuing education and training to physicians and scientists with an active interest in interventional radiology or cardiovascular imaging techniques. CIRSE promotes the exchange of ideas and information to further define the role, direction and goals of cardiovascular and interventional radiology as a subspecialty of radiology.
About BioSphere Medical, Inc.
BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, has pioneered and is commercializing minimally invasive diagnostic and therapeutic products based on its proprietary bioengineered microsphere technology. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with unique beneficial properties for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products have continued to gain acceptance in this emerging procedure as well as in a number of other new and established medical treatments.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding BioSphere's expectation that HepaSphere will prove to be beneficial to addressing unmet needs in liver cancer, improves patient outcomes and increase the effectiveness of embolization. BioSphere uses words such as "believes," "may," "anticipates," "estimates," "expects," "should," "intend," and similar expressions to identify these forward-looking statements. There are a number of important factors that may affect BioSphere's actual results, many of which are beyond BioSphere's control and are difficult to predict. These important factors include, without limitation, risks relating to: the failure of BioSphere to obtain and/or maintain necessary regulatory approvals, either in the United States or internationally, with respect to the manufacture and sale of its HepaSphere product and other products and product candidates; the failure of BioSphere to successfully achieve widespread market acceptance of its HepaSphere product in procedures for the treatment of liver cancer; risks relating to BioSphere's ability to obtain and maintain patent and other proprietary protection for its products and product candidates, including HepaSphere; competitive pressures; the inability of BioSphere to raise additional funds in the near term to finance its strategic initiatives; general economic and market conditions; and the risk factors described in the section titled " Risk Factors" in BioSphere's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, as filed by the Company with the Securities and Exchange Commission, and described in other filings made by the Company from time to time with the Securities and Exchange Commission. The forward-looking statements in this press release are made as of the date of this press release and the Company disclaims any obligation to update these forward-looking statements as a result of changed events, circumstances or otherwise.
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|Date:||Aug 24, 2006|
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