BioSphere Medical Reports Continued Favorable Results in Phase I Clinical Trial of Embosphere Microspheres.

Business Editors and Biotechnology/Medical Writers

ROCKLAND, Mass.--(BW HealthWire)--March 13, 2001

Company Also Reports Another Presentation at Major Medical

Conference Indicates Superiority of Uterine Fibroid Embolization 

Over Surgical Alternatives

BioSphere Medical, Inc. (Nasdaq:BSMD) today announced updated results of its U.S. Phase I clinical trial to evaluate the company's Embosphere(R) Microspheres for uterine fibroid embolization (UFE). UFE is a minimally invasive, catheter-based procedure in which tiny particles are injected into the blood vessels supplying the fibroids to occlude their blood supply. Uterine fibroids can cause excessive bleeding, pain and disfigurement. Approximately six million women in the U.S. seek treatment for them annually.

Favorable Phase I Six Month Data Reported

At the 26th Annual Scientific Meeting of the Society of Cardiovascular and Interventional Radiology (SCVIR), Dr. Gary Siskin of Albany Medical College reported that three month follow-up data was available on all 30 patients and six month on 24 patients. Menstrual bleeding improved markedly by three months, and this improvement has remained durable through six months. Other important indices, including pelvic pain, pelvic discomfort and urinary symptoms, all improved in 92% of the patients presenting with these symptoms. Quality of life scores and overall patient satisfaction paralleled symptom improvements. Six month ultrasound imaging follow-up showed significant decreases in both uterine volume and dominant fibroid volume.

According to Dr. James Spies, Associate Professor of Radiology at the Georgetown University Medical Center and the Phase I principal investigator, "the six month data continues to be very encouraging and has so far reinforced our belief that UFE is a desirable alternative to surgical procedures such as hysterectomy (removal of the uterus) and myomectomy (surgical removal of the fibroids). We are looking forward to confirming these results in the larger population of women who will receive UFE procedures in the Phase II pivotal clinical trial of Embosphere Microspheres which is currently under way."

Stanford University Study Shows UFE Superior To Surgical Alternatives

At the same meeting, Dr. Mahmood Razavi of Stanford University reported that UFE was more effective than surgery in reducing bleeding and as effective in relieving pain and pressure. According to the Stanford Report, he further found that UFE "... patients lost significantly less blood during the procedure, spent less time in the hospital and were able to resume normal activities up to five times more quickly than women who had their fibroids surgically removed."

"The Stanford University study and Phase I data support our belief that UFE will become the treatment of choice in the treatment of many women with uterine fibroids," said John Carnuccio, BioSphere Medical's president and chief executive officer. "These and other positive reports on UFE further validate our strategic focus on new and rapidly emerging embolotherapy markets."

Incidence of Uterine Fibroids

It is estimated that over 25 million women in the U.S. have uterine fibroids and that 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 UFE will grow substantially during the next five years.

About BioSphere Medical

BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company with a microsphere platform technology. The Company's primary focus is 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.

BioSphere Medical's lead product, Embosphere 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 Microspheres for uterine fibroid 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 Microspheres for use in general embolization procedures, including uterine fibroid embolization.

The company believes that micro-therapeutic technologies, such as its proprietary microsphere platform, are enabling the rapid development of a new, "micro-interventional" market. Micro-therapeutic devices will permit clinicians to provide treatment in an even more effective and minimally invasive manner than with catheter-based interventional technologies alone. BioSphere Medical believes that its microsphere technology will also have a direct influence in broadening the definition of embolotherapy to potentially include tissue bulking, drug delivery, tissue repair and tissue regeneration. In December 2000, BioSphere Medical announced a strategic alliance with Inamed Corporation to supply proprietary microspheres for dermal bulking applications.

Safe Harbor Statement

This press release contains forward-looking statements that involve risks and uncertainties, including those relating to clinical results, to the ability of the Company to achieve necessary regulatory approvals for UFE, to the expected growth of the market for UFE, and to become the leader in the rapidly growing field of embolotherapy. 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 Microspheres and HepaSphere SAP(TM) Microspheres technologies for uterine fibroid 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 development of the Company's existing and new markets; 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.