January 28, 2008 - BioSphere Medical Inc., a medical device company that has pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors, and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy, today reported that the Medical Device Department of the State Food and Drug Administration of the People’s Republic of China has approved BioSphere’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.
In China, the annual incidence of hepatocellular carcinoma (HCC or primary liver cancer) is approximately 350,000, roughly half of the total worldwide incidence. The high occurrence of HCC in Asia in general and China in particular is attributed to a 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. As the cancer progresses, physicians may embolize the resulting tumors, and may often perform multiple procedures on each patient.
For more information: www.biospheremed.com