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BioSphere Medical to Present at Vascular Targeting Agents Therapeutic and Diagnostic Development Conference in Cambridge, Mass.

Posted on: Monday, 8 November 2004, 21:00 CST

BIOSPHERE MEDICAL, (NASDAQ:BSMD), Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer and is the fifth leading cancer killer in the world. HCC is most frequently associated with chronic viral hepatitis B and C infections, but also includes cirrhosis as a result of alcohol abuse. According to Globocan 2002, there are about 500,000 new cases of HCC diagnosed worldwide every year.

The liver is also a common site for metastatic cancer, especially from colorectal cancer (CRC). In the U.S., about 150,000 newly diagnosed CRC cases occur annually and about half eventually metastasize to the liver. The metastatic liver tumor is life-limiting in a large proportion of these cases.

Surgical removal of the tumor is the best treatment option for liver cancer, but the majority of patients are not eligible for surgical intervention. There is a need for treatments that would improve the prognosis for these patients.

Strategic Research Institute's inaugural International Conference on Vascular Targeting Agents will focus on the science and applications of agents that target the blood supply to cancerous tumors. James Krom, Principal Scientist at BioSphere Medical, will be presenting a talk on "Microspheres for Internal Beta-Radiation Therapy" on November 9, 2004, at the Hyatt Regency in Cambridge, MA. A relatively new treatment option for the management of HCC and metastatic CRC tumors is internal radiotherapy using radioactive microspheres. There are few published clinical trials regarding this treatment modality, but claims of substantial survival benefits are beginning to emerge.

BioSphere Medical is developing a microsphere formulation that is capable of transporting radiotherapy via the vascular system to cancerous liver tumors. The goal is the development of a microsphere that absorbs certain materials used in nuclear medicine, to provide simultaneous diagnostic imaging capability in addition to radiotherapy. Simultaneous diagnostic imaging will allow clinicians to measure precisely the radiation dose to the tumor, a feature lacking in currently-available radioactive microspheres. The inability to determine the radiation dose to the tumor has hampered the development and clinical acceptance of the use of radioactive microspheres to treat liver cancer. BioSphere's approach will also facilitate "customization" of the radiotherapy for each patient. Promising preclinical results have been obtained with non-radioactive isotopes, and a development program using radioisotopes is underway.

About BioSphere Medical, Inc.

BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company focused on applying our proprietary microsphere technology to medical applications using embolotherapy techniques. Our core technologies, patented bio-engineered polymers and manufacturing methods, are used to produce miniature spherical beads with uniquely beneficial properties for a variety of medical applications. Our principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. Our products are already beginning to gain acceptance in this rapidly emerging procedure as well as in a number of other new and established medical treatments. Our strategy is two fold. First, we are seeking to grow the embolotherapy business worldwide, specifically the UFE procedure, by increasing awareness of availability of this procedure. Second, we are seeking to maintain our current technology leadership by the continuous introduction of new products and product improvements, both through internally developed and externally acquired technologies, that improve and broaden the use of embolotherapy techniques.

We have received clearance in a number of countries, including the United States, Canada, Australia and the European Community, which allow us to sell our products for use in general embolization procedures, including uterine fibroid embolization.

Cautionary Statement Regarding Forward-Looking Statements - This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to the safety and effectiveness of UFE and the company's expectations that acceptance of UFE by medical providers will fuel market growth. The Company uses words such as "plans,""seeks,""projects,""believes,""will,""may,""anticipates,""estimates,""should'" and similar expressions to identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon the Company's beliefs and assumptions. There are a number of important factors that may affect the Company's actual performance and results and the accuracy of its forward-looking statements, many of which are beyond the Company's control and are difficult to predict. These important factors include, without limitation, risks relating to: the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its microspheres technologies for uterine fibroid embolization, targeted liver embolization and other applications; the failure of the Company to achieve or maintain necessary regulatory approvals, either in the United States or internationally, with respect to the manufacture and sale of its products and product candidates; risks relating to the Company's ability to obtain and maintain patent and other proprietary protection for its products; the absence of or delays and cancellations of, product orders; delays, difficulties or unanticipated costs in the introduction of new products; competitive pressures; the inability of the Company to raise additional funds to finance the development, marketing, and sales of its products and general economic conditions. These risk factors are further detailed in the in the Company's report on Form 10-K for the year ended December 31, 2002 and Form 10-Q for the quarter ended September 30, 2003 and other periodic reports filed by the Company with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's estimates as of the date of this release. The Company anticipates that subsequent events and developments may cause its forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances after the date of this press release.

Source: Business Wire

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