BioSphere Medical Appoints New Director of Research and Director of Quality and Regulatory Affairs.

Business/Technology Editors and Health/Medical Writers

ROCKLAND, Mass.--(BW HealthWire)--Oct. 2, 2000

Accomplished Managers Join Company's Effort to Advance on Regulatory

Approval and Expand Technology Base for Future Product Development

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 it has appointed a new Director of Quality and Regulatory Affairs and Director of Research.

Alexander Schwarz, Ph.D. was named Director of Research and John D. Bonasera was named Director of Quality and Regulatory Affairs. Dr. Schwarz has over eight years of industrial experience since completing post-doctoral studies and was most recently a senior scientist at Nextran, Inc., an affiliate of Baxter International Inc. Bonasera comes to BioSphere with more than 20 years experience and was previously Director of Regulatory Affairs and Quality Assurance at Arrow International, Inc.

"We are excited to have Alex and Jack joining our team at this critical time," said Jon McGrath, BioSphere Medical's Vice President, Worldwide Research and Development. "Alex's extensive experience in the analytical chemistry and biotechnology fields makes him unusually capable to direct the research efforts we are planning. His knowledge will be instrumental in enabling us to achieve one of our key product development objectives: combining active agents with our core microsphere technology. This will allow the company to pursue new market opportunities for a wide variety of applications, including treatment of certain cancers."

"Jack's depth of experience in both quality assurance and regulatory affairs will make him a key player across the organization as we strive to position Embosphere(R) Microspheres as the global standard for embolization therapy," McGrath continued. "Jack joins us with an extensive and successful background in US and international regulatory affairs as well as implementation and management of quality systems in the biomedical device field. He will be a tremendous asset for BioSphere Medical worldwide, but especially now as we expand clinical studies in the United States using our lead product, Embosphere(R) Microspheres for uterine artery embolization, a rapidly emerging alternative therapy for uterine fibroids."

As senior scientist at Nextran, Inc., an affiliate of Baxter International Inc. that provides organ transplant technologies and services, Dr. Schwarz was responsible for development and manufacturing of chemical and biological reagents for use in preclinical trials. In his previous position as bioprocess development engineer with BioSepra, Inc., BioSphere Medical's predecessor company, Dr. Schwarz was responsible for the development of purification processes for a variety of biomolecules with a focus on monoclonal antibody purification. He has been published in 20 publications and has been issued four U.S. patents. Dr. Schwarz received his M.Sc., magna cum laude, in Chemistry from the University of Cologne, Germany and his Ph.D., magna cum laude, in Biochemical Engineering from the University of Bonn, Germany.

As director of regulatory affairs and quality assurance at Arrow International, Inc., a leading provider of catheterization products for the treatment of heart and vascular disease, Mr. Bonasera directed quality and regulatory strategy development, and was responsible for the company's FDA regulatory efforts relative to clinical trials for a variety of innovative products. His quality assurance efforts included leadership of the company's successful initiative to obtain ISO 9002 and ISO 9001 Certification. Prior to joining Arrow in 1994, Mr. Bonasera was manager of quality assurance and regulatory affairs at Surgilase, Inc. He previously held regulatory and quality assurance management positions at Coulter Diagnostics, Nova Biomedical and Johnson & Johnson's Ortho Diagnostic Systems unit. Mr. Bonasera holds a B.A. in Biology and Psychology from the University of Massachusetts, Boston.

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 the treatment of 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 develop new products, to obtain necessary regulatory approvals and to commercialize its products internationally. 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.