BioSphere Medical Announces Publication of Favorable Phase I Clinical Trial Results Of Embosphere-R- Microspheres.

Business/Technology Editors & Health/Medical Writers

ROCKLAND, Mass.--(BW HealthWire)--Sept. 25, 2001

Investigators Report Significant Decrease In Uterine Fibroid Tumor

Symptoms After Treatment With Embosphere Microspheres

BioSphere Medical (Nasdaq: BSMD - news) today announced publication in the Journal of Vascular and Interventional Radiology of favorable results of its Phase I clinical trial to evaluate the company's Embosphere Microspheres for uterine fibroid embolization (UFE). UFE is a minimally invasive, catheter-based procedure in which tiny particles are injected into the blood vessels supplying the fibroids to occlude their blood supply. Uterine fibroids can cause excessive bleeding, pain and disfigurement. Approximately six million women in the U.S. seek treatment for them annually.

The Company announced earlier this month that it has completed enrollment and treatment of the embolization arm of its pivotal Phase II clinical trial of Embosphere Microspheres for uterine fibroid embolization. This study is designed to enable the Company to expand the indications for use of Embosphere Microspheres to include uterine fibroid embolization, following FDA clearance. This product was cleared by the FDA in April 2000 for the treatment of hypervascularized tumors and arteriovenous malformations.

Significant Decrease In The Impact Of Symptoms Reported

According to the article, "Fifty-six percent had a substantial or severe symptom impact during menstrual periods at baseline, but this decreased to 4% at 3 months and 0% at 6 months. Similarly, 33% had substantial or severe symptom impact between periods at baseline, which reduced to 4% at 3 months and 0% at 6 months." This was a Phase I study of 30 patients with symptomatic fibroid tumors.

"We are delighted to see these results published in such a prestigious journal," said John Carnuccio, President and CEO of BioSphere Medical. "It is exciting to have such encouraging data presented in this and other major publications and forums."

The trial was conducted at Georgetown University Medical Center, Miami Cardiac and Vascular institute and Roxborough Memorial Hospital. James Spies, M.D., Chairman of Interventional Radiology at Georgetown University Medical Center was the study's principal investigator and lead author.

Dr. James F. Benenati, a co-author of the publication in the Journal of Vascular and Interventional Radiology, is a member of the Company's Medical Advisory Board.

About BioSphere Medical, Inc.

BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company with a microsphere platform technology. The Company's primary focus is embolotherapy, the treatment of tumors and vascular malformations by occluding their blood supply. The Company is pioneering the use of its patented and proprietary bioengineered microspheres as a new class of embolic.

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 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 may use words such as "expects," "plans," "seeks," "projects," "believes," "may," "anticipates," estimates," and similar expressions to identify these forward-looking statements. These forward-looking statements include the Company's expectations regarding the Company's ability to successfully conduct clinical trials of, and develop and commercialize, its Embosphere Microspheres for uterine fibroid embolization. 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 and commercialize 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; the delay 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. In addition, the forward-looking statements included in this press release represent the Company's estimates and beliefs as of the date of this release. The Company anticipates that subsequent events and developments may cause the Company's estimates and beliefs to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this release.