Study Indicates that Uterine Fibroid Embolization May be Safer than Abdominal Myomectomy and Reduce the Number of Hysterectomies

Uterine Fibroid Embolization provides a safe and lower cost alternative to myomectomy and hysterectomy in cases of Uterine Fibroids.

NEWS RELEASE

FOR IMMEDIATE RELEASE         September 29, 2003

FOR MORE INFORMATION
MEDIA CONTACT:            
ALAN GAUDYNSKI, APR         Sandi M. Duxbury
(262) 796-8525            (781) 681-7951
agaudynski@prwisconsin.com      sduxbury@biospheremed.com

INVESTOR RELATIONS CONTACT:
Robert Palladino
(781) 681-7925

Study Indicates that Uterine Fibroid Embolization May be Safer than Abdominal Myomectomy

ROCKLAND, Mass.--(BUSINESS WIRE)-September 29, 2003--BIOSPHERE MEDICAL, (NASDAQ:BSMD), Approximately 20-40 percent of women 35 years and older experience uterine fibroids. Some statistics say that approximately 80% of African-American women have fibroids. Until recently, invasive, in-patient surgery or hysterectomy, were the only options for the removal of these non-cancerous uterine fibroids.    
Mahmood Razavi, MD, an interventional radiologist in the Department of Vascular and Interventional Radiology at Stanford University, recently completed a study, the results of which were published in the June, 2003 edition of the American Journal of Roetenology entitled: Abdominal Myomectomy Versus Uterine Fibroid
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UFE vs. Abdominal Myomectomy

Embolization in Treatment of Symptomatic Uterine Leiomyomas." (Uterine Fibroid Embolization, or UFE, is also known as Uterine Artery Embolization, or UAE.) The objective of this study was to compare treatment efficacy and complications of abdominal myomectomy with those of uterine fibroid embolization in women with symptomatic uterine fibroids. UFE is an out-patient, uterus-saving procedure using a catheter and an embolic agent, such as Embosphere® 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.
   Dr. Razavi and his colleagues analyzed the outcomes of 111 consecutive patients who underwent abdominal myomectomy (n=44) or fibroid embolization (n=67) over a 30 month period. The mean ages of the two groups were 37.7 years (range, 28-48) and 44.2 years (range, 31-56 years), respectively. A questionnaire and review of medical records assessed all procedure-related complications and changes in symptoms. Length of hospital stay, time until resumption of daily activities and pain medication requirements after the procedure were also analyzed.
   The results were statistically significant in favor of uterine fibroid embolization (UFE).
   Success rates for improving
                  Myomectomy      UFE
Menorrhagia               64%      vs   92%
Pain                  54%      vs   74%
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UFE vs. Abdominal Myomectomy

Mass effect               91%      vs   76%
Complication rate            25%      vs   11%
Hospital stay (days)            2.9      vs   0
Narcotic use (days)            8.7      vs   5.1
Back to activities (days)         36      vs   8
   Dr. Razavi concludes, Uterine fibroid embolization is a less invasive and safer treatment option in women with symptomatic leiomyomas (fibroids) than surgical myomectomy. Menorrhagia may be better controlled with UFE, and myomectomy may be a better option in women with mass effect."
   Also, the Departments of Radiology and Obstetrics and Gynecology at Georgetown University in Washington, DC, recently published a paper in the Journal of Vascular and Interventional Radiology (JVIR 2002; 13:1207-1210), which showed lower costs for UFE ($6708) vs. surgical abdominal myomectomy ($7630). These costs include hospitalization and professional costs, but did not include the costs related to patients returning to normal daily activities: 36 days for the myomectomy vs. 8 days for UFE.
   Although UFE has been performed in the U.S. since 1997, and to date almost 50,000 procedures have been performed worldwide, many women experiencing fibroids are unaware of UFE as an option to invasive myomectomy surgery or hysterectomy. The primary reason for a hysterectomy is not cancer, but uterine fibroids, which accounts for one-third to one-half of the 600,000 hysterectomies every year. UFE is overall a safe and viable alternative to surgery and is performed throughout the United States. Web site:
www.ask4ufe.com or toll free: 1-877-ASK-4UFE.
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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 our EmboSphere ® Microspheres and the company's expectations that it will successfully promote awareness and market and sell its products through its sales, marketing and education programs. The Company uses words such as "plans," "seeks," "projects," "believes," "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 the Embosphere® Microspheres and EmboGold(TM) Microsphere 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 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 June 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.