Biosensors Announces IDE Approval for BioFreedom™ U.S. Trial
SINGAPORE, May 5, 2014 /PRNewswire/ -- Biosensors International Group, Ltd. ("Biosensors" or the "Company", Bloomberg: BIG SP; Reuters: BIOS.SI; SGX: B20), a developer, manufacturer and marketer of innovative medical devices, announced today that the U.S. Food and Drug Administration (FDA) recently granted conditional Investigational Device Exemption (IDE) approval for a U.S.-based clinical trial of the BioFreedom™ polymer-free drug-coated stent (DCS) system.
The BioFreedom U.S. IDE Feasibility Trial is designed to collect additional safety and effectiveness data for the BioFreedom system and to support a future pivotal IDE study. The Company believes this is the first clinical study within the U.S. evaluating polymer-free DCS, and also the first U.S. clinical study of a device benefitting from the use of the Biolimus A9™ (BA9™) drug. The trial design is multicenter and prospective, enrolling 100 patients at up to five centers. Due to the unique features of BioFreedom, the FDA agreed with a post-implant strategy requiring only three months of dual anti-platelet therapy (DAPT) for this study.
Another important BioFreedom trial, LEADERS FREE, is applying a one-month DAPT strategy in patients at high risk of bleeding to further establish the product's safety and efficacy profile. The goal is to demonstrate that treatment with BioFreedom delivers the safety profile of a bare-metal stent with the anti-restenotic benefit of a drug-eluting stent.
BioFreedom represents the latest development in Biosensors' stent technology, featuring a micro-structured abluminal surface that permits the controlled release of BA9 without the use of a polymer or other carrier. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents. In its First in Man (FIM) study, treatment with BioFreedom demonstrated excellent 12-month late lumen loss and sustained safety up to four years, including absence of definite and/or probable stent thrombosis.
"IDE approval for the BioFreedom U.S. trial represents a major milestone for the company because it is our first U.S.-based clinical study of a stent," commented Biosensors' CEO Dr. Jack Wang. "The U.S. is the largest national market for medical devices. We look forward to introducing our unique and ground-breaking interventional cardiology products there."
BioFreedom received CE Mark approval in January 2013 and is currently available in limited and selected markets.
Media/Investor Relations Contact
Wong Teck Yenn
Director, Investor Relations
About Biosensors International Group, Ltd
Biosensors International Group, Ltd. develops manufactures and markets innovative medical devices, aiming to improve patients' lives through pioneering medical technology. Founded in 1990, we were listed on the Mainboard of the Singapore Stock Exchange in 2005.
The Group currently operates through four business units ("BU"): the Cardiovascular BU, composed primarily of the BioMatrix™ family of drug-eluting stents and stent technologies such as BA9; the Cardiac Diagnostic BU, including Spectrum Dynamics products that offer advanced medical imaging and clinical solutions to help interventional cardiologists determine the most appropriate treatment for patients; the Peripheral Intervention BU, offering solutions for the treatment of patients with peripheral arterial disease; and the Critical Care Products BU.
The Group has operations worldwide and is headquartered in Singapore.
For more information, please visit www.biosensors.com.
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SOURCE Biosensors International Group, Ltd.