Healthcare Industry News:  Uterine Fibroids 

Devices Oncology Regulatory

 News Release - January 10, 2006

BioSphere Medical Reports Regulatory Approvals of EmboCath(R) Infusion Catheter and Segway(R) Guidewire in the People's Republic of China

Market Clearance Provides Access for BioSphere Delivery System Products to the World's Largest Population of Primary Liver Cancer Patients

ROCKLAND, Mass.--(HSMN NewsFeed)--Jan. 10, 2006-- BioSphere Medical, Inc. (Nasdaq: BSMD ), a medical device company that pioneered the use of bioengineered microspheres to treat Uterine Fibroids, hypervascularized tumors and vascular malformations, today reported that its embolic delivery system products, EmboCath Infusion Catheter, or "EmboCath," and Segway Guidewire, or "Segway," were approved by the Medical Device Department of the State Food and Drug Administration of the People's Republic of China (China) for clinical use in embolization procedures.

In China, BioSphere plans to sell both its delivery system products and the company's EmbosphereŽ Microspheres for embolization procedures. The use of Embosphere Microspheres for embolization is currently under review by the Chinese regulatory authorities based on a clinical trial using Embosphere Microspheres in a treatment protocol for patients with primary liver cancer (Hepatocellular Carcinoma, or HCC). The company expects market clearance for the use of Embosphere Microspheres in China during the first half of 2006.

Richard Faleschini, president and chief executive officer of BioSphere Medical, commented, "The approval of BioSphere delivery system products in China is part of our commitment to the growth of embolic therapies and is also an important step in our efforts to address the clinical needs of an estimated 350,000 patients in China with primary liver cancer."

Liver cancer patients in China comprise roughly half of the total worldwide patient population. The incidence of primary liver cancer in Asia is attributed to a higher incidence of hepatitis B and C in the region. Many primary liver cancer patients are diagnosed at a level of tumor development where they are no longer good candidates for surgical intervention, and many physicians believe that minimally invasive embolic therapy may be used to slow the advance of cancer in conjunction with other therapies.

Delivery systems are an essential part of a minimally invasive embolic procedure. Interventional radiologists deliver embolics to the site of service through the blood vessels with catheters threaded via guidewires under live imaging. Attributes that aid the success of the procedure include extreme flexibility, combined with durability and consistent performance, allowing the physician to reach the site of service and deliver Embosphere Microspheres with precision.

EmboCath and Segway are currently approved for use in the United States, Canada, the European Union, and other countries throughout the world.

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 applications 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 for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic Uterine Fibroids using a procedure called uterine fibroid embolization, or UFE. The company's products continue to gain acceptance in this rapidly 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 uterine fibroid embolization (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 approval of use of Embosphere Microspheres in China, the use of embolic treatment to slow the advance of the cancer in conjunction with other therapies, the company's plans to address the clinical needs of liver cancer patients in China, the company's expectations with regard to the execution of its planned business strategies, increasing market acceptance of its products, improvement of performance of its business outside the United States and expectations with respect to commercialization of its products. 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 and its distributors to successfully market and sell the company's products; 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; risks relating to 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; and general economic and market conditions, as well as the risk factors described in the section titled " Factors That May Affect Future Results " in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, 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.


Source: BioSphere Medical

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