BioSphere Medical Completes Enrollment of All Patients in the Phase II Pivotal Trial; Company Expects to File for FDA Clearance in Second Quarter of 2002.

Business & Health/Medical Editors

ROCKLAND, Mass.--(BW HealthWire)--Jan. 22, 2002

BioSphere Medical(TM), Inc. (Nasdaq:BSMD) today announced that it has completed enrollment of all 50 patients for the hysterectomy arm of its Phase II clinical trial to treat uterine fibroids.

The Company completed the first arm of the trial, treatment of 102 patients with the Uterine Fibroid Embolization (UFE) procedure in September 2001. A total of 11 U.S. clinical sites participated in this study.

Data from the study will be part of an application to the U.S. Food and Drug Administration (FDA) for expanded U.S. marketing clearance of the Embosphere(R) Microspheres for treatment of uterine fibroids.

The hysterectomy group of the Phase II trial is designed to measure complications, adverse events, changes in symptoms, quality of life, and patient satisfaction in women that underwent hysterectomy to treat fibroid disease. The outcome data of these patients will be compared with the study group who underwent UFE using Embosphere(R) Microspheres.

"We believe completion of enrollment of this study is a major milestone, keeping us on track for an anticipated FDA submission for the UFE indication in the second quarter," stated John M. Carnuccio, President and Chief Executive Officer of BioSphere Medical. "Until very recently, women suffering the debilitating symptoms of uterine fibroids had few options for durable treatment. We are excited to be moving ever closer to a point, in the foreseeable future, when this least invasive treatment alternative is expected to be both broadly accepted and universally available."

Preliminary results of this clinical study have been presented at multiple society meetings in the past year and will be updated at the International Symposium of Endovascular Therapy (ISET) this week in Miami.

BioSphere Medical initiated the Phase I clinical trial of its microsphere products for treatment of uterine fibroids in January 2000 under an Investigational Device Exemption (IDE) granted by the FDA, enrolling 30 patients. Following positive Phase I three-month post treatment results, the Company commenced the Phase II clinical trial in October 2000. Six-month data from the Phase I clinical study was published in September 2001, by Dr. James Spies MD, the study's principal investigator, in the Journal of Vascular and Interventional Radiology.

Uterine fibroid embolization is a catheter-based procedure that treats uterine fibroids by starving the blood supply that feeds them. During the procedure, guided by external imaging, an interventional radiologist injects tiny, spherical shaped gel-like particles into the arteries leading to the fibroids. The particles are then guided by blood flow into the vessels surrounding the fibroids and lodges there, stopping flow of nutrients to the tumors.

Uterine fibroids affect more than 25 million women in the United States and about six million of these women seek treatment annually. More than 200,000 of these patients undergo invasive hysterectomies for fibroids and many others have fibroids removed surgically. Industry sources have stated that worldwide demand for UFE will grow substantially during the next five years. BioSphere Medical was the first company to begin clinical testing under an FDA approved IDE for UFE.

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.

BioSphere Medical's lead products, Embosphere(R) Microspheres and EmboGold(TM) Microspheres, have been cleared by the FDA for marketing for hypervascularized tumors and vascular malformations. The Company is currently conducting clinical trials of Embosphere(R) Microspheres for uterine fibroid embolization (UFE) 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 sell Embosphere(R) Microspheres for use in general embolization procedures, including uterine fibroid embolization.

Cautionary Statement Regarding Forward-Looking Statements - This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," and similar expressions to identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon the Company's beliefs and assumptions. There are a number of important factors that may affect the Company's actual performance and results and the accuracy of its forward-looking statements, many of which are beyond the Company's control and are difficult to predict. These important factors include, without limitation, risks relating to 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, commercialize and achieve widespread market acceptance of the Embosphere(R) Microspheres and EmboGold(TM) Microsphere technologies for uterine fibroid embolization, targeted liver 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; delays, difficulties or unanticipated costs in the introduction of new products; competitive pressures; the inability of the Company to raise additional funds 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, 2000 filed by the Company with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent BioSphere Medical's estimates as of the date of this release. BioSphere Medical anticipates that subsequent events and developments will cause its estimates to change. However, while BioSphere Medical may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing BioSphere Medical's estimates or views as of any date subsequent to the date of this release.