BioSphere Medical Announces First Treatment in Phase II Uterine Artery Embolization Clinical Trial; Initial Clinical Sites Now Enrolling Patients in Final Trial Phase.

Business/Technology Editors & Health/Medical Writers

ROCKLAND, Mass.--(BW HealthWire)--Dec. 14, 2000

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 the first patient treatment in the Phase II pivotal trial of the company's leading product, Embosphere(R)Microspheres, to treat uterine fibroids.

The treatment was performed by Robert Worthington-Kirsch, at Roxborough Memorial Hospital in Philadelphia, Pennsylvania. Dr. Worthington-Kirsch has performed over 850 uterine artery embolization (UAE) procedures, more than any other physician in the world. "I am delighted to be a part of this important clinical study," said Worthington-Kirsch. "It will be the first time in the U.S. that the results of this procedure are evaluated using a validated measurement system and also the first time UAE is systematically compared with the standard surgical alternative, hysterectomy."

"We are excited to report the start of the final phase of this trial," said John Carnuccio, BioSphere Medical's president and chief executive officer. "We are fortunate to have assembled such a strong group of investigators for this study. The investigators include Dr. Worthington-Kirsch; Dr. James Spies, Associate Professor of radiology at Georgetown University Medical, the study's principal investigator; Dr. James Benenati, at Miami Cardiac and Vascular Institute; Dr. Gary Siskin, at Albany Medical Center; and Dr. John Lipman, at Piedmont Hospital in Atlanta. In the near future, we expect to announce the remaining two members of our clinical investigative team."

The study is designed to measure safety and compare symptoms of fibroid disease in 100 treated patients before and after treatment and also to compare these results with a separate group of patients who have been treated with hysterectomy, which is the surgical removal of the uterus. Patients treated in both arms of the study will be followed for at least a year to compare the long-term results in each group.

About Uterine Fibroids and Uterine Artery Embolization

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. Industry sources have stated that worldwide demand for UAE is expected to grow substantially during the next five years.

Uterine artery embolization is a rapidly emerging, less invasive alternative to hysterectomy in which the blood flow to the fibroid is interrupted by a stream of small particles, delivered through a small catheter placed in the artery supplying the fibroids. The interruption of nutrients to the fibroid causes irreversible injury to the tumor and, according to published data, generally results in substantial reduction in the symptoms associated with fibroid disease, including excessive bleeding, pain and other symptoms. According to industry sources, nearly 15,000 women have been treated in the U.S. with this new treatment.

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 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 has 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 achieve necessary regulatory approvals for UAE and to commercialize its products internationally for an array of applications. 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; failure 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; failure 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.