BTG Receives CE Mark Reclassification for DC Bead

August 2, 2016—BTG plc announced that it has obtained European CE Mark from the Notified Body British Standards Institution following completion of the reclassification of the company’s DC Bead and DC BeadM1 as class III medical devices. DC Bead and DC BeadM1 are drug-eluting embolic beads capable of loading and releasing compatible chemotherapeutic agents. BTG advised that the conformity assessment has resulted in clear indication statements to permit use of the beads as class III medical devices in transarterial chemoembolization for the treatment of liver tumors, and that the assessment takes into account the characteristics of DC Bead and DC BeadM1 with regard to their ability to administer medicines and the product-specific nonclinical and clinical data supporting the safe and effective conditions for the use of DC Bead in the approved clinical setting.

The devices are described as being compatible with doxorubicin for the local treatment of tumors in patients with hepatocellular carcinoma. Doxorubicin can be loaded before embolization and, as a secondary action, will elute a local, controlled, and sustained dose to the tumor after embolization. DC Bead and DC BeadM1 are also intended to embolize the vessels supplying malignant colorectal cancer metastasized to the liver. The devices are compatible with irinotecan, stated BTG.