BioSphere Medical's EmboCath, Segway devices receive approval for use in China

By Angela McDaniels

Seattle, Jan. 10 - BioSphere Medical Inc. said its embolic delivery system products, EmboCath Infusion Catheter and Segway Guidewire, have been approved by the Medical Device Department of the State Food and Drug Administration of the People's Republic of China for clinical use in embolization procedures.

In addition to the delivery system products, BioSphere plans to sell its Embosphere Microspheres for embolization procedures in China. 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).

The company said it expects market clearance for the use of Embosphere Microspheres in China during the first half of 2006.

"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," president and chief executive officer Richard Faleschini said in a company news release.

Liver cancer patients in China make up roughly half of the total worldwide patient population, according to BioSphere. The incidence of primary liver cancer in Asia is attributed to a higher incidence of hepatitis B and C in the region.

Delivery systems are an essential part of a minimally invasive embolic procedure, the company said. Interventional radiologists deliver embolics to the pertinent site through the blood vessels with catheters threaded via guidewires under live imaging.

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

BioSphere Medical is a medical device company based in Rockland, Mass., that has pioneered and is commercializing minimally invasive diagnostic and therapeutic applications based on its proprietary bioengineered microsphere technology.

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