Biosensors Receives CE Mark Approval for BioFreedom™
SINGAPORE, Jan. 28, 2013
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 represents the latest development in Biosensors' stent technology,
featuring a micro-structured abluminal surface which permits the controlled
release of Biolimus A9™ (BA9™) without the use of a polymer. BA9 is a highly
lipophilic anti-restenotic drug developed by Biosensors specifically for use
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™ Liberte™ 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™ family of drug-eluting stents, we
are rapidly emerging as a leader in the global coronary stent market. The
recent launch of the Axxess™ self-expanding bifurcation drug-eluting stent and
the development of the BioFreedom™ drug-coated stent further establish our
All three stents incorporate Biolimus A9™ (BA9™), 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
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.
Media/Investor Relations Contact
Biosensors International Group
Mr. Wong Teck Yenn
Director, Investor Relations
Tel: (65) 6213 5708
SOURCE Biosensors International Group, Ltd.
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