BioSphere to Market Microspheres in China

Company eyes large opportunity in treating liver cancer

Rockland, MA-based BioSphere Medical reported this week that the Medical Device Department of the People’s Republic of China approved BioSphere’s Embosphere Microspheres for clinical use in treating vascular embolizations, arteriovenous malformations, hypervascularized tumors, and symptomatic uterine fibroids.

Approximately 200 million Chinese have health coverage, creating a market opportunity close to that found in the U.S. Notably, the opportunity for hepatocellular carcinoma (HCC or primary liver cancer) treatment represents roughly half of the total worldwide, with an annual incidence of approximately 350,000.

The high occurrence of HCC in China is attributed to the high historical prevalence of the hepatitis B and C viruses. These viruses damage the liver and can contribute in time to the development of primary liver cancer. BioSphere’s technology can be used by physicians to embolize the resulting tumors.

Embolotherapy works by reducing blood flow to target areas of the body; the procedure is performed by injecting agents, usually particles, through a catheter and into the blood vessels that feed these target areas. By selectively blocking the target tissue’s blood supply, the deprived tissue will either be destroyed or become devitalized.

In November 2002, the company received FDA 510(k) clearance to market its Embosphere Microspheres in the U.S. The company’s, Embosphere Microspheres and EmboGold Microspheres, have a number of beneficial properties that make them well suited for embolotherapy. The uniform, spherical shape and soft, slippery surface, make the particles easy to inject through small catheters, resulting in a more even distribution within the vessel network. Biosphere provides these products in a variety of precise sizes, so they can be selected to target occlusion of specific sized vessels to produce predictable results.

There are two types of embolization that are used within the liver: bland embolization, which is embolization without chemotherapy; and chemoembolization, which is embolization in combination with chemotherapeutic drugs.

BioSphere expects to commence shipments of Embosphere Microspheres to China in the first quarter of 2008. Richard Faleschini, President and CEO of BioSphere, commented, “We believe that China has the potential to be an attractive market for us, and a catalyst for potential future revenue growth.”

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