BioSphere Medical, Inc. Completes Patient Enrollment for Phase I Uterine Artery Embolization Clinical Trial.

Business/Technology Editors & Health/Medical Writers

ROCKLAND, Mass.--(BW HealthWire)--July 21, 2000

Company Also Launches Major Marketing Push

for General Embolotherapy Applications

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, today announced that it has completed patient enrollment for its Phase I uterine artery embolization (UAE) clinical trial. The Company also reported on the launch of its campaign to market its proprietary flagship product, Embosphere(R) Microspheres, for general embolotherapy applications.

Phase I Clinical Trials

"We initiated the Phase I clinical trial of Embosphere(R) Microspheres for treatment of uterine fibroids in January 2000 under an Investigational Device Exemption (IDE) granted by the FDA," John Carnuccio, BioSphere Medical's president and chief executive officer said. "We have completed treating all 30 patients, who have now had the uterine artery embolization procedure with Embosphere(R) Microspheres. A one-year monitoring period will be conducted with each patient. We are also in active discussions with the FDA to commence the final phase of this study in the near future."

BioSphere Medical believes that it is well positioned to capitalize not only on the significant market for general embolotherapy, but also, in the future, on growing physician and patient interest in embolization as a treatment for uterine fibroids in Europe and the United States. Uterine fibroids affect more than 25 million women in the U.S., and about six million of these women seek treatment annually. More than 200,000 of these patients undergo hysterectomies for fibroids, while many others have the fibroids removed surgically.

Sales and Marketing Ramp-up

"Since receiving FDA 510(k) clearance for Embosphere(R) Microspheres for general embolotherapy applications in April, we have focused on identifying and engaging potential early adopters and have witnessed an encouraging and positive reception for our product," Carnuccio said. "We recently completed hiring our first group of direct sales representatives and our initial sales training was conducted by Bob Phelps, our V.P. of Sales. The selling and marketing effort is complemented by the addition of Don Anderson who was recently hired as V.P. of U.S. Marketing. Don is delighted to join the team and contribute his 20 years of marketing experience to attack this new and significant opportunity in embolotherapy."

"At the same time, we have launched our first U.S. marketing campaign, aimed at generating greater awareness of Embosphere(R) Microspheres among patients and interventional radiologists around the country," Carnuccio said. "Armed with a fully implemented sales organization and comprehensive marketing platform, we are poised to capitalize on this growing worldwide market."

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 blood flow. The Company is pioneering the use of patented and proprietary bioengineered microspheres as a new class of embolics.

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(R) Microspheres 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.