BioSphere Medical Receives Approval of Canadian Device Licensing Application for Embosphere Microspheres; Another Milestone Achievement in Worldwide Commercialization Strategy.

Business/Technology Editors & Health and Medical Writers

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jan. 18, 2000

BioSphere Medical, Inc. (OTCBB:BSMD), a medical device company that is pioneering the use of patented and proprietary bioengineered microspheres in embolotherapy, announced today that it has received approval of its Canadian Device Licensing Application for Embosphere(R) Microspheres. Embolotherapy is the treatment of tumors and vascular defects by inhibiting blood flow.

According to John M. Carnuccio, president and chief executive officer of BioSphere Medical, "Canadian licensing approval represents yet another milestone achievement in our growth strategy, which is focused on commercializing our platform microsphere technology in embolotherapy. In Canada, we have seen significant interest in the product by the interventional radiologist and interventional neuroradiologist communities, with many indicating that they will use the product as soon as it is available."

Embosphere Microspheres are currently CE Mark approved in the European Economic Area. The Company announced last week that it has received Australian approval to market the product. In November 1999, BioSphere Medical received approval of its Investigational Device Exemption application from the FDA to initiate clinical evaluation of Embosphere Microspheres for use in Uterine Artery Embolization (UAE). UAE is the occlusion of the blood supply to uterine fibroids to reduce their size and alleviate associated symptoms, including bleeding, pain and disfigurement. It is estimated that approximately 25 million women in the U.S. have uterine fibroids, and that approximately 5.5 million seek treatment annually. In May 1999, the Company filed a 510(k) application in the U.S. for use in general embolization procedures commonly performed by interventional radiologists and interventional neuroradiologists.

Carnuccio concluded, "We are very pleased with the progress we have made in our strategy to commercialize Embosphere Microspheres internationally. Having received Canadian, Australian and European approvals, we believe we are building a solid foundation from which we can grow BioSphere Medical for the long-term."

BioSphere Medical, Inc., based in Marlborough, Massachusetts, is a medical device company focused on embolotherapy, the treatment of tumors and vascular disease by inhibiting blood flow. The Company is pioneering the use of bio-engineered microspheres as a new class of embolic devices.

This press release contains forward-looking statements that involve risks and uncertainties, including those relating to the future sale of the Company's products and the long-term growth of the Company. 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 Microspheres technology for Uterine Artery Embolization and other applications; to provide patent and other proprietary protection for the Company's products and to garner the necessary U.S. regulatory approvals for such technology; 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.