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Biosensors International Group Ltd announces IDE approval for Biofreedom U.S. trial

Monday, 5 May 2014 08:06am EDT 

Biosensors International Group Ltd:Says U.S. Food and Drug Administration (FDA) recently granted conditional Investigational Device Exemption (IDE) approval for U.S.-based clinical trial of BioFreedom(tm) polymer-free drug-coated stent (DCS) system.BioFreedom U.S. IDE Feasibility Trial is designed to collect additional safety and effectiveness data for BioFreedom system and to support a future pivotal IDE study.Company believes this is first clinical study within U.S. evaluating polymer-free DCS, and also first U.S. clinical study of device benefitting from use of Biolimus A9(BA9) drug. 

Company Quote

-0.0050 -0.70%
16 Sep 2014