BioSphere Medical Receives FDA 510k Clearance for Embosphere Microspheres; Achieves Major Milestone in Global Commercialization Strategy.

Business Editors and Health/Medical Writers

ROCKLAND, Mass.--(BW HealthWire)--April 27, 2000

BioSphere Medical, Inc., (NASDAQ:BSMD) a medical device company that is pioneering the use of bioengineered microspheres to treat tumors and vascular malformations by occluding their blood supply, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use of Embosphere(R) Microspheres in the United States. Embolization is a method of treating tumors and vascular disease by inhibiting blood flow.

"FDA clearance of Embosphere Microspheres to treat hypervascularized tumors and arteriovenous malformations is a major milestone for our company, and a noteworthy event in the advancement of embolotherapy in the United States," stated BioSphere Medical President and Chief Executive Officer John Carnuccio. "Embolization is less invasive than traditional surgical procedures, and we believe we can now offer physicians and their patients in the United States an improved product and significant advancement in the effectiveness of this procedure and technology."

Commenting on the success of the Company's global commercialization strategy, Carnuccio said, "The clearance of Embosphere Microspheres in the United States, coupled with marketing approvals in Europe, Canada and Australia, highlights the significant progress that the Company has made in our first year dedicated to the advancement of embolotherapy. We look forward to leveraging the success of the past year to capture a significant share of emerging, high-volume embolization markets around the globe in 2000 and beyond. Our product will be distributed in the United States by a consultative direct sales force complemented by a clinical support team, both of which we are in the process of building. As of today, we are ready to take orders."

In May 1999, BioSphere Medical filed the now-cleared U.S. FDA 510(k) application for its product Embosphere Microspheres to treat hypervascularized tumors and arteriovenous malformations. BioSphere Medical has received CE Mark approval in Europe, which allows the Company to sell the product for use in general embolization procedures in the 19 countries of the European Economic Area. In January 2000, Biosphere Medical received approval to sell the product for use in general embolization procedures in Australia and Canada. Also in January 2000, the Company began Phase I clinical evaluations of Embosphere Microspheres for use in Uterine Artery Embolization (UAE) pursuant to the approval by the FDA of its separate Investigational Device Exemption (IDE). UAE is the occlusion of the blood supply to uterine fibroids to reduce their size and alleviate associated symptoms.

Corporate Profile

BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company that is pioneering the use of patented and proprietary bioengineered microspheres in embolotherapy - the occlusion of the blood supply to tumors and vascular malformations. Embolization is a procedure performed primarily by interventional radiologists to treat hypervascularized tumors and arteriovenous malformations throughout the body, including the increased interest in uterine fibroids.

This press release contains forward-looking statements that involve risks and uncertainties, including but not limited to the Company's ability to grow sales of Embosphere Microspheres for the long term. 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 Microsphere technology for Uterine Artery 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 periodic reports filed by the Company with the Securities and Exchange Commission.