BioSphere Medical, Inc. (NASDAQ: BSMD) announced today that a study published in the March 2007 issue of Journal of Vascular and Interventional Radiology concluded that over the long term, uterine fibroid embolization (?UFE?) using BioSphere Medical's Embosphere® Microspheres is safe and effective, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction.

The multi center prospective study is entitled ?Long-term Outcome from Uterine Fibroid Embolization with Tris-acryl Gelatin Microspheres: Results of a Multicenter Study.? Spies, et al. The study focused on patients undergoing UFE with tris-acryl gelatin microspheres (TAGM) ? the material that comprises Embosphere Microspheres. Three-year clinical outcomes were assessed. Measures of the outcomes included the Ruta Menorrhagia Questionnaire, patient self-assessment of symptoms and impact on activities, patient satisfaction, and health-related quality of life as measured by the SF-12 (collectively, ?the measurable indices?). Long-term re-intervention rates were also assessed.

Among the key findings of the study were:

  • 72% of patients had known outcomes at three years after treatment.
  • 88.4% of the patients with known outcomes completed a three-year follow-up without the need for a major intervention.
  • 8.3% of the patients underwent fibroid surgery within three years.
  • All measurable indices demonstrated sustained or continual improvement from baseline to 36 months, representing a high level of durable symptom control, health-related quality of life, and patient satisfaction.
  • On the basis of this and other studies, the majority of UFE procedures performed in the United States and Europe are currently performed using tris-acryl gelatin microspheres (Embosphere Microspheres).
  • Limitations of the study were frankly identified by the authors, but these did not undermine the results. Rather, they concluded, ?This study provides new data with respect to broad improvements to long-term health status in women undergoing UFE.?

Richard Faleschini, BioSphere Medical's president and chief executive officer, said, ?The three-year outcomes reported in this study represent the longest UFE follow-up period for any of the currently marketed spherical embolics. These findings are compelling and validating. Embosphere Microspheres, the first embolic cleared by the FDA for UFE and the most clinically studied spherical embolic, is cited as the dominant product used to treat symptomatic uterine fibroids. Patients without intervention experienced significant improvement in symptoms such as bleeding, pelvic pain, and urinary problems, while reporting substantial improvement in their quality of life. This latest data further supports our belief that in the majority of cases of symptomatic fibroids, UFE should be considered as a primary therapy that produces impactful and durable symptom relief.?

This study was the basis for BioSphere's 510(k) clearance from the Food and Drug Administration, or FDA, to market our Embosphere Microspheres for UFE in November 2002. Initial results were published in the American Journal of Obstetrics and Gynecology in 2004.

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 Microsphere 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 Company's belief's regarding the suitability of its Embosphere Microsphere products as primary therapy for UFE. 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 HepaSphere Microspheres and 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 as 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.