BioSphere Medical Reports Regulatory Approvals

ROCKLAND, Mass.–(BUSINESS WIRE)–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 Embosphere(R) 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.