BioSphere Medical Completes Enrollment of Embolization Patients in Pivotal Trial.

Business/Technology Editors & Health/Medical Writers

ROCKLAND, Mass.--(BW HealthWire)--Sept. 5, 2001

100 Patients Treated Using Company's Lead Product,

Embosphere(R)Microspheres for Uterine Fibroids 

BioSphere Medical (Nasdaq: BSMD), a medical device company that is pioneering the use of bioengineered microspheres in embolotherapy, announced today that all 100 patients have been treated in the Uterine Fibroid Embolization (UFE) arm of its Phase II clinical trial to treat uterine fibroids.

BioSphere Medical initiated the Phase I clinical trial of its microsphere products for treatment of uterine fibroids in January 2000 under an Investigational Device Exemption (IDE) granted by the FDA, enrolling 30 patients. Following positive Phase I three-month post treatment results, the Company commenced the Phase II clinical trial in October 2000. Successful completion of Phases I and II would set the stage to apply for FDA clearance to market Embosphere(R)Microspheres for treatment of uterine fibroids in the U.S.

"We are very pleased to complete the enrollment of the UFE arm ahead of schedule," said John M. Carnuccio, BioSphere Medical's president and chief executive officer. "The hysterectomy arm now has well over 50% of the required patients and we expect to complete enrollment of these patients soon. In addition, we continue to be enthused by the clinical results of Phase I to be presented at the International Society of Endovascular Therapy (ISET) Conference in January 2002."

The Phase II study is designed to measure safety and assess symptoms of fibroid disease in 100 patients before and after their UFE procedures. The UFE patients will also be compared with a separate group of patients who have undergone hysterectomies. Patients treated in both arms of the study will be followed for at least one year to compare the long-term results in each group.

Uterine fibroids affect more than 25 million women in the U.S. and about six million of these women seek treatment annually. More than 200,000 of these patients undergo invasive hysterectomies for fibroids and many others have fibroids removed surgically. Industry sources have stated that worldwide demand for UFE will grow substantially during the next five years. BioSphere Medical was the first company to begin clinical testing under an FDA approved IDE for UFE.

About BioSphere Medical, Inc.

BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company focused on embolotherapy, the treatment of tumors and vascular malformations by occluding their blood supply. The Company is pioneering the use of patented and proprietary bioengineered microspheres as a new class of embolics.

BioSphere Medical's lead product, Embosphere Microspheres, was cleared by the FDA in April 2000 for marketing for hypervascularized tumors and vascular malformations. The Company is currently conducting clinical trials of Embosphere Microspheres for uterine fibroid embolization (UFE) in the United States under an Investigational Device Exemption (IDE) granted by the FDA. BioSphere Medical has received CE Mark approval in the European Community and approvals in Canada and Australia which allow the Company to sell Embosphere Microspheres 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. The Company uses words such as "expects," "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," 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. These forward-looking statements include the Company's expectations regarding the Company's success in Phase I and Phase II FDA clinical trial enrollments and results as well as the future worldwide demand for the UFE procedure. 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 achieve or maintain necessary regulatory approvals, either in the United States or internationally, with respect to the manufacture and sale of its products; to successfully develop, commercialize and achieve widespread market acceptance of the Embosphere(R) Microspheres and HepaSphere SAP(TM) Microsphere technologies for uterine fibroid embolization, targeted liver embolization and other applications; to provide patent and other proprietary protection for the Company's 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; general economic conditions; as well as those risk factors detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2000 filed by the Company with the Securities and Exchange Commission.