BioSphere Medical, Inc. (NASDAQ: BSMD) announced today that a study published in the New England Journal of Medicine on January 25, 2007 concluded that, in women with symptomatic uterine fibroids, minimally invasive uterine fibroid embolization (UFE) shows an equivalent one-year quality-of-life benefit when compared to hysterectomy and myomectomy. The study was conducted from November 2000 to May 2004 at 27 hospitals in the United Kingdom, with one-year follow-up completed in November 2005. The patients were at least 18 years of age. Each had one or more symptomatic uterine fibroids measuring at least 2cm and visible under MRI. The study is available at www.nejm.org.

Among the key findings of the NEJM study were:

  • Women who underwent uterine-sparing embolization stayed in the hospital an average of 1 day compared to 5 days for those who underwent surgery.
  • Women undergoing embolization returned to work after an average of 20 days, compared to the surgical patients, who took an average of 62 days to return to work.
  • UFE was more cost effective than surgery (in the U.K. health-care system).
  • After the first month following surgery, quality-of-life measurements were significantly in favor of women who underwent embolization. After one year, quality-of-life benefits for women who underwent embolization and those who underwent surgery were not statistically different.
  • After one year only 12% of UFE patients experienced major adverse events, as compared to 20% for hysterectomy or myomectomy. 34% of UFE patients experienced minor complications, the majority of which were fever, pain, and inflammation, as compared to 20% for hysterectomy or myomectomy.
  • A minority of women (9%) in the UFE group required a secondary intervention to treat persistent or recurrent symptoms at 12 months.

Richard Faleschini, BioSphere Medical's president and chief executive officer, said, ?The results of this randomized study are, in our view, quite compelling. Women who underwent UFE had an equivalent quality-of-life benefit at one year when compared to the women who had either hysterectomy or myomectomy. In addition, women who had UFE experienced a significantly faster recovery time, and returned to their activities of daily living in a fraction of the time of those who had surgery. Beyond these quality-of-life benefits, which are significant, this study demonstrated substantial cost savings to the (U.K.) health-care system, and an increase in productivity to employers because women could return to work much sooner. Although the study concluded that the faster recovery after UFE should be weighed against the need for further treatment in a minority of patients, we believe the evidence has continued to build and converge on the conclusion that in the majority of cases of symptomatic fibroids, uterine fibroid embolization should be among the first-line therapies.?

About BioSphere Medical, Inc.

BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, has pioneered and is commercializing minimally invasive diagnostic and therapeutic products based on its proprietary bioengineered microsphere technology. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with unique beneficial properties, which the Company believes have the potential for use in a variety of medical applications. BioSphere's principal focus is the application of its Embosphere® Microspheres product for the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products have continued to gain acceptance in this emerging procedure as well as in a number of other new and established medical treatments.

BioSphere Medical has received clearance in many countries, including the United States, Canada, Australia, the European Community, and Latin America, which allows the Company to sell its products for use in general embolization procedures, including uterine fibroid embolization. The terms uterine fibroid embolization (UFE) and uterine artery embolization (UAE) are generally used interchangeably in the literature. The most common side effect of UFE is ?post-embolization syndrome,? a collection of symptoms including abdominal pain, discomfort, low-grade fever and nausea. UFE is currently contraindicated for women who are, or who intend to become, pregnant, because the effects of UFE on the ability of a woman to conceive, and to carry a fetus to term, have not been determined.

Cautionary Statement Regarding Forward-Looking Statements - This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the expected benefits of UFE when compared to hysterectomy and myomectomy. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," ?should,? ?intend,? 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 and product candidates;
  • the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its products, including, without limitation, widespread market acceptance of its lead product, Embosphere Microspheres for the treatment of UFE and its recently launched QuadraSphere? Microspheres;
  • the Company's ability to obtain and maintain patent and other proprietary protection for its products and product candidates;
  • 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 in the near term to finance the development, marketing, and sales of its products;
  • general economic and market conditions; and
  • the risk factors described in the section titled ?Risk Factors? in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, as filed by the Company with the Securities and Exchange Commission, and described in other filings made by the Company from time to time with the Securities and Exchange Commission.

In addition, the forward-looking statements included in this press release represent the Company's estimates as of the date of this release. The Company anticipates that subsequent events and developments may cause its forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances after the date of this press release.