BioSphere Medical Reports Study Published in Journal of Vascular and Interventional Radiology.

Business Editors/Health/Medical Writers

ROCKLAND, Mass.--(BUSINESS WIRE)--Dec. 8, 2003

Study Indicates Increasing Acceptance by Gynecologists of UFE as Treatment for Symptomatic Uterine Fibroids 

BIOSPHERE MEDICAL, (NASDAQ:BSMD), Approximately 20-40 percent of women 35 years and older experience uterine fibroids and approximately 50% of African-American women have fibroids.

All too frequently, a woman with symptomatic fibroids faces a hysterectomy or myomectomy to relieve her symptoms caused by the fibroids. More recently, a minimally invasive procedure called uterine fibroid embolization (UFE) has become widely available. UFE, which is performed by an Interventional Radiologist, is a uterus-saving procedure using a catheter and an embolic agent, such as BioSphere Medical's Embosphere(R) Microspheres, to cut off the blood supply to the fibroid tumors. Symptoms, such as excessive bleeding and pelvic pain, are relieved as the fibroids shrink.

Some of the initial challenges to the growth of UFE procedures have been due to a lack of physician and patient awareness. However, a recent article published in the December 2003 issue of the Journal of Vascular and Interventional Radiology reveals a more positive trend for gynecologists to offer UFE as a first line therapy for fibroid patients, which is expected to help fuel market growth of this procedure.

Dr. Michael Tal and Elizabeth Kagan Arleo from the Department of Diagnostic Radiology, section of Interventional Radiology at Yale University School of Medicine performed a baseline patient survey in July 2000 and repeated the survey in April 2002 to investigate if women believed that their gynecologist were discussing and offering UFE as a treatment option. Both surveys analyzed the results of 21 patients, for a total of 42 patients. The survey asked questions related to their gynecologist's initial opinion of UFE, which treatment options were offered, who initiated the discussion of UFE, and whether the patient returned to the same gynecologist after her UFE. The initial survey in 2000 showed that 76% of their patient's believed that their gynecologists were opposed or strongly opposed to UFE as an option. The updated survey in 2002 suggests that only 33% of patients believed that their gynecologists were opposed or strongly opposed to UFE. In 2000, the patients in the survey indicated that approximately 5% of gynecologists offered UFE as a treatment option whereas in April 2002, this number increases to 38%.

"UFE is clearly a benefit to women who are suffering the debilitating effects of fibroids, but are hesitant to having major surgery," indicates Dr. Tal. "The process of performing UFE has improved tremendously since 1998; thus, gynecologists should be including UFE in treatment discussions with all fibroid patients. Interventional radiologists have drastically improved patient care, pain management, and patient selection over the course of almost a decade."

Elizabeth Kagan Arleo, fourth year medical student at Yale, comments, "The fact that 62% of gynecologists still do not offer UFE as a treatment option is disconcerting, especially since informed consent dictates discussion of all treatment options available."

Dr. Tal concludes, "Uterine fibroid embolization is a less invasive and safer treatment option in women with symptomatic fibroids than surgery. The trend toward gynecologist acceptance of this safe procedure should only enhance the patient's overall quality of life."

For more information on uterine fibroid embolization, go to www.ask4ufe.com or call toll free: 1-877-ASK-4UFE.

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.