BioSphere Medical Receives FDA Approval to Initiate Clinical Trials for Uterine Artery Embolization; Phase I Study of EmbosphereR Microspheres to Begin by Year End.

MARLBOROUGH, Mass.--(BW HealthWire)--Nov. 11, 1999--

BioSphere Medical, Inc. (OTC BB: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 Investigational Device Exemption (IDE) 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.

BioSphere Medical President and Chief Executive Officer John Carnuccio stated, "We are very pleased that the FDA has granted approval to initiate clinical trials of Embosphere Microspheres for use in Uterine Artery Embolization. This allows us to begin the Phase I study before year-end, a significant regulatory milestone. We believe we are the first company to receive FDA approval to conduct a study to evaluate UAE for treatment of uterine fibroids. Of particular note was the cooperative effort we received from the FDA, which resulted in a rapid and timely reply to our IDE submission."

The Embosphere Microspheres Phase I U.S. study is scheduled to include 30 patients at three sites: Georgetown University Medical Center, headed by lead investigator James B. Spies, M.D., Vice Chair of Radiology and Chief of Interventional Radiology. Dr. Spies is one of the leading spokespersons on UAE for the Society of Interventional Radiology (SCVIR). Also conducting the study are Dr. R.L. Worthington-Kirsch, Section Head of Interventional Radiology at the Delaware Valley Imaging Center in Pennsylvania; and Dr. James F. Benenati, Medical Director, Peripheral Vascular Lab, Miami Cardiac & Vascular Institute. The Miami Cardiac and Vascular Institute, founded by Dr. Barry Katzen, is recognized as one of the leading and most advanced endovascular centers in the world.

Said Dr. Spies, "There is considerable interest in improving embolic materials and technology among physicians in this field. The evaluation of Embosphere Microspheres in the context of an FDA approved study is exciting, as we are hopeful that this product will represent an advance in the effectiveness of this procedure and thus patient care."

In addition, BioSphere Medical will conduct a parallel UAE study using the U.S. protocol at Hopital Lariboisiere in Paris, France, where the first UAE procedures were performed over a decade ago, and where Embosphere Microspheres were developed in cooperation with Dr. Alex Laurent. Dr. Jean-Pierre Pelage, who has conducted and published animal research comparing Embosphere Microspheres to other embolization materials, will serve as principal investigator.

According to Mr. Carnuccio, "We hope to generate sufficient favorable patient data in nine to twelve months to enable us to submit an application to the FDA for a Phase II study. By working cooperatively with the FDA, we are moving closer to providing physicians and patients with an attractive alternative to traditional open surgery and an improved product to address the growing uterine artery embolization market."

Embosphere Microspheres are currently CE Mark approved and sold in the European Economic Area. 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. In October 1999, Biosphere Medical filed a Canadian Device Licensing Application for Embosphere Microspheres.

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. 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 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.