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BioSphere gets market clearance for microspheres in China

BioSphere Medical has said that the State Food and Drug Administration of the People's Republic of China has approved the company's Embosphere Microspheres for clinical use for vascular embolizations, arteriovenous malformations, hypervascularized tumors, and symptomatic uterine fibroids.

BioSphere expects to commence shipments of Embosphere Microspheres to China in the first quarter of 2008.

Richard Faleschini, president and CEO of BioSphere, said: “We believe that among these covered lives are a large number of patients who have and are being treated for benign and malignant hypervascularized tumors, such as uterine fibroids and hepatocellular carcinoma, respectively. Therefore, we believe that China has the potential to be an attractive market for us, and a catalyst for potential future revenue growth.”