Embosphere Microspheres Uterine Fibroid Treatment Results Presented At European Radiology Meeting.

Business/Technology Editors

ROCKLAND, Mass.--(BUSINESS WIRE)--Oct. 11, 2000

Study Shows That Company's Lead Product Provides Documented

Relief from Uterine Fibroid Symptoms

BioSphere Medical, Inc. (Nasdaq: BSMD), a medical device company that is pioneering the use of bioengineered microspheres to treat hypervascularized tumors and vascular malformations by occluding their blood supply, announced today that results of a clinical study, performed in Europe, of the Company's Embosphere(R) Microspheres product in the treatment of uterine fibroids were presented in September by Dr. Jean-Pierre Pelage of Hopital Lariboissiere in Paris to the Congress of Interventional Radiology Society of Europe (CIRSE) meeting at Maastricht, Netherlands.

Dr. Pelage reported that symptoms of severe bleeding were resolved in 19 of 20 patients and were improved in the 20th patient. Excellent tumor size reduction was also noted. All patients tolerated the procedure well and no long-term side effects were reported. The patients were evaluated at one, six and 12 months following treatment. A final evaluation will be made at 24 months post procedure.

"Dr. Pelage's findings represent yet another significant milestone for Biosphere Medical," said John Carnuccio, the company's president and chief executive officer. "This is the first study to assess the long-term safety and efficacy of uterine artery embolization (UAE) treatment with Embosphere(R) Microspheres, and the results validate our positive expectations about the ease of use and treatment results with our product."

"These clinical results to date support our expectation that, pending FDA approval, Embosphere(R) Microspheres will become the global standard for UAE therapy," Carnuccio said. "Dr. Pelage's presentation to many of the world's preeminent interventional radiologists at CIRSE is yet another example of the rapid progress we are making and the growing awareness of data to demonstrate the potential benefits of our product for UAE and an expanding array of additional applications." The company is separately continuing its clinical studies in the U.S. to collect additional data supporting the use of its product in uterine artery embolization.

BioSphere Medical currently markets Embosphere(R) Microspheres for general embolization therapy purposes in the United States, and is conducting U.S. clinical trials of the product for UAE under an Investigational Device Exemption granted by the FDA. The company also markets Embosphere(R) Microspheres for general and UAE therapy in several European nations.

Uterine fibroids affect more than 25 million women in the U.S., and about six million of these women are symptomatic. More than 200,000 undergo hysterectomies for fibroids, while many others have the fibroids removed surgically. Industry sources have stated that worldwide demand for UAE will grow substantially during the next five years.

About BioSphere Medical

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.

The company's lead product, Embosphere(R) 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(R) Microspheres for uterine artery embolization in the United States under an Investigational Device Exemption (IDE) granted by the FDA. BioSphere Medical received CE Mark approval in the European Community and approvals in Canada and Australia which allow the company to market Embosphere(R) Microspheres for use in general embolization procedures, including uterine artery embolization.

This press release contains forward-looking statements that involve risks and uncertainties, including those relating to the ability of the Company to commercialize its products internationally for an array of applications and the Company's expectation regarding the ease of use, treatment results and global marketing acceptance of its Embosphere(R) Microsphere product. Among the important factors that could cause actual events to differ materially from those indicated by forward-looking statements in this release are 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 and commercialize the Embosphere(R) Microspheres and HepaSphere SAP(TM) Microsphere technologies for uterine artery 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; the delay in the introduction of new products; competitive pressures; the inability of the Company to raise additional funds, if needed, 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, 1999 and other periodic reports filed by the Company with the Securities and Exchange Commission.