BioSphere Medical, Inc. (NASDAQ: BSMD) today announced a podium presentation and key abstracts related to the Company's embolic products for the treatment of symptomatic uterine fibroids, liver cancer and arteriovenous malformations have been accepted at the Society for Interventional Radiologists (SIR) 32nd Annual Scientific Meeting being held March 1-6, 2007 in Seattle, Washington.

On March 4, 2007 Shinichi Hori, MD, the inventor of HepaSphere? Microspheres, will present an abstract titled ?Hepatocellular Carcinoma Treated by Superabsorbent Polymer Microsphere (SAP-MS, HepaSphere) Bland Embolization.? The purpose of the study was to evaluate and estimate the clinical usefulness of primary tumor effects of bland embolization of hepatocellular carcinoma (HCC) using HepaSphere SAP Microspheres without the combination of chemotherapeutic drugs.

Data from additional abstracts will be available as poster presentations at the event. They are:

  • ?TACE with Microsphere HepaSphere Loaded with Chemotherapeutic Agent: Early Experience in an Italian Multicentric Study.? M. Grosso, et al. This will present the early results from BioSphere Medical's European HepaSphere Registry. The Registry gathered data from sites in Cuneo, Pavia, and Pisa using BioSphere Medical's HepaSphere Microspheres loaded with chemotherapeutic agents doxorubicin or epirubicin for TACE (Transcathether Arterial Chemoembolization) in patients with unresectable HCC.
  • ?A Radiopaque Spherical Embolic Material for Prediction of Shunting Caliber in High-Flow AVM and Hypervascular Tumors.? S. Hori, et al. In this study, BioSphere Medical's SAP-MS HepaSphere Microspheres were evaluated for their clinical usefulness in the treatment of high-flow arteriovenous malformations and hypervascular neoplastic tumors.
  • "In Vitro Characterization of Cisplatin-Loaded Superabsorbent Polymer Microspheres Designed for Chemoembolization." N. Maeda, et al. The purpose of the study was to investigate in vitro characterization of cisplatin-loaded superabsorbent polymer (SAP) microspheres designed for chemoembolization.

Additionally, data will be presented at SIR on the Cardiovascular and Interventional Radiological Society of Europe's (CIRSE) Foundation Uterine Fibroid Embolization Registry with respect to baseline population characteristics and technical aspects of the procedure. As with the US FIBROID Registry, the majority of patients in the CIRSE registry were treated with BioSphere Medical's embolic products.

Gary Saxton, BioSphere Medical's executive vice president and chief operating officer, said, ?SIR 2007 is one of the premier events for interventional radiologists from around the world, serving as a forum to introduce the latest clinical research. We are excited to have an opportunity to showcase our platform technologies and related delivery systems for the treatment of uterine fibroids, primary liver cancer, hypervascularized tumors and arteriovenous malformations at this year's meeting.?

Richard Faleschini, BioSphere Medical's president and chief executive officer, said, ?These presentations at the SIR are part of our ongoing plan to progressively build our position in embolotherapy generally, and more specifically in interventional oncology. In 2007, this began with the QuadraSphere presentation and live-case demonstration at the recent International Symposium on Endovascular Therapy (ISET?January), continues with these presentations at the SIR meeting, and moves forward with various presentations and events at future meetings such as Global Embolization Symposium and Technologies (GEST?April), World Conference on Interventional Oncology (Washington, D.C.?May), and Cardiovascular and Interventional Radiological Society of Europe (CIRSE?September).?

About QuadraSphere Microspheres

QuadraSphere is technically identical in all respects to HepaSphere. BioSphere's 510(k) clearance for QuadraSphere does not include specific indications for the treatment of primary and metastatic liver cancer. FDA regulations require that BioSphere conduct formal clinical trials prior to seeking to claim the use of QuadraSphere for the treatment of a specific disease or condition, such as primary and metastatic liver cancer, while European Union regulations do not require trials for this class of medical device. Accordingly, in order for BioSphere to seek FDA clearance to promote the use of QuadraSphere for the embolization of primary and metastatic liver cancer, it must conduct clinical trials in the United States.

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 plans to progressively build its position in embolotherapy and interventional oncology. 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.