BioSphere Medical Receives CE Mark Approval for Transarterial Chemoembolization Using HepaSphere™ Microspheres

ROCKLAND, Mass.--(BUSINESS WIRE)--BioSphere Medical, Inc. (NASDAQ: BSMD) (“BioSphere”), 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 announced that it has received CE Mark approval for Transarterial Chemoembolization (TACE) of Hepatocellular Carcinoma (HCC) using HepaSphere™ Microspheres (HepaSphere) and Doxorubicin. As a condition of the CE Mark approval, BioSphere will conduct a 100-patient, post-market registry study in 10-15 European centers. CE Mark approval denotes conformity with European standards for safety and allows certified devices to be placed in the market in European Union countries.

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