BioSphere Medical Product Featured in Live Case Presented At International Symposium On Endovascular Therapy.

Business Editors & Health/Medical Writers

ROCKLAND, Mass.--(BUSINESS WIRE)--Feb. 2, 2001

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World's Leading Interventional Radiologists Witness Procedure

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 that a live uterine artery embolization ("UAE") case using the company's Embosphere(R) Microspheres product was performed to a large audience at the International Symposium on Endovascular Therapy (ISET) meeting in Miami, Florida.

The case was performed by Dr. James Benenati at the Miami Cardiac and Vascular Institute (MCVI), the sponsor of the ISET meeting. The case was part of the company's pivotal Phase II clinical study, designed to demonstrate the safety and efficacy of Embosphere(R) Microspheres to treat uterine fibroids. This clinical trial is being conducted under an Investigational Device Exemption (IDE) granted by the U.S. FDA. MCVI is one of five sites currently enrolling patients in this study.

"We are delighted to be a continuing part of this study," said Dr. Benenati. "Our experience today mimics our positive results to date with Embosphere(R) Microspheres. Based on experience over the past several years, we believe that UAE has the potential to become the preferred treatment over hysterectomy in the future."

"We continue to see increasing enthusiasm about this product," said John Carnuccio, BioSphere Medical's president and chief executive officer. "With each new definitive milestone event, we reinforce the leadership position we have already established in this rapidly emerging new therapeutic modality."

During the conference, several papers were presented by key opinion leaders reinforcing the growth and acceptance of the procedure. As part of his presentation, Dr. James Spies, of Georgetown University Medical Center and the study's Principal Investigator highlighted the results of the Phase I UAE study. His summary of the observations were:

-- Embosphere(R)Microspheres are easy to deliver in micro-catheters.

-- Endpoint of embolization results in greater residual uterine artery flow,
but no difference in imaging outcome.

-- The residual flow may reduce pain associated with embolization.

-- Residual flow may reduce the chance of injury to myometrium, but requires
further study.

-- The volume of microspheres used was initially high, but decreased with
experience (short learning curve).

-- This is the first study to demonstrate that UAE controls menorrhagia using
validated measures.

The Phase II 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 will be treated with hysterectomy, the surgical removal of the uterus.

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. We believe worldwide demand for UAE will 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. According to already published data, the interruption of nutrients to the fibroid causes irreversible injury to this tissue and results in substantial reduction in the symptoms associated with fibroid disease. These symptoms may include excessive bleeding, pain and other side effects associated with the substantial volume of the fibroids, which may cause pressure on adjacent tissue and organs.

According to industry sources, nearly 15,000 women have been treated in the U.S. with this new treatment.

About BioSphere Medical, Inc.

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.

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, Form 10-Q for the quarter ended September 30, 2000 and other periodic reports filed by the company with the Securities and Exchange Commission.