Biosensors Receives CE Mark Approval for BioFreedom(TM)
SINGAPORE, Jan. 28, 2013 /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, today announced CE Mark approval for its polymer-free drug-coated stent (DCS), BioFreedom(TM).
BioFreedom represents the latest development in Biosensors’ stent technology, featuring a micro-structured abluminal surface which permits the controlled release of Biolimus A9(TM) (BA9(TM)) without the use of a polymer. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents.
CE Mark approval for BioFreedom was supported by strong data from the BioFreedom First in Man study. In this study BioFreedom was compared to Boston Scientific’s Taxus(TM) Liberte(TM) drug-eluting stent (DES). At 12 months, BioFreedom demonstrated equivalent efficacy, measured by in-stent late lumen loss, compared with Taxus Liberte, with a trend towards superiority. Median in-stent late lumen loss in patients receiving BioFreedom was reduced to 0.17 mm as compared with a median in-stent late lumen loss of 0.35 mm in the Taxus Liberte group. Three year clinical results, presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in October 2012, showed similar rates of MACE (Major Adverse Cardiac Events) between BioFreedom and Taxus Liberte, with no evidence of stent thrombosis in either group.
To further evaluate BioFreedom in a larger patient population, Biosensors recently announced initiation of enrolment in LEADERS FREE, the world’s first prospective, randomised double-blind trial between a DCS and bare-metal stent (BMS), exclusively involving patients at high risk of bleeding. The study has been designed to confirm that BioFreedom is as safe as a BMS in this patient group, and can deliver the anti-restenotic benefit of a DES, with only a one-month course of dual anti-platelet therapy administered to all patients.
This trial will provide additional data to support the launch of BioFreedom in select markets during 2013. The full commercial launch is currently anticipated during 2014.
About Biosensors International Group, Ltd
Biosensors International develops, manufactures and markets innovative medical devices for interventional cardiology and critical care procedures. We aim to improve patients’ lives through pioneering medical technology that pushes forward the boundaries of innovation.
With the increasing use of the BioMatrix(TM) family of drug-eluting stents, we are rapidly emerging as a leader in the global coronary stent market. The recent launch of the Axxess(TM) self-expanding bifurcation drug-eluting stent and the development of the BioFreedom(TM) drug-coated stent further establish our technology leadership.
All three stents incorporate Biolimus A9(TM) (BA9(TM)), an anti-restenotic drug developed and patented by Biosensors specifically for use with drug-eluting stents. Both the BioMatrix stent family and the Axxess stent feature a unique abluminal biodegradable polymer coating, which fully degrades into carbon dioxide and water after six to nine months as it releases BA9. The BioMatrix stent family features workhorse stent platforms for a broad range of lesions, and the Axxess stent employs a self-expanding stent platform specifically designed for treating bifurcation lesions. BioFreedom, a completely polymer?free stent abluminally coated with BA9, is currently undergoing clinical evaluation.
For more information, please visit www.biosensors.com.
Certain statements herein include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally can be identified by the use of forward-looking terminology, such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “project” or “continue” or the negative thereof or other similar words. All forward looking statements involve risks and uncertainties, including, but not limited to, customer acceptance and market share gains, competition from companies that have greater financial resources; introduction of new products into the marketplace by competitors; successful product development; dependence on significant customers; the ability to recruit and retain quality employees as Biosensors grows; and economic and political conditions globally. Actual results may differ materially from those discussed in, or implied by, the forward-looking statements. The forward-looking statements speak only as of the date of this release and Biosensors assumes no duty to update them to reflect new, changing or unanticipated events or circumstances.
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SOURCE Biosensors International Group, Ltd.