WASHINTON D.C., Oct. 26 /Xinhua-PRNewswire-FirstCall/ -- Biosensors
International Group, Ltd. (Bloomberg: BIG SP), which is listed on the
Mainboard of the Singapore Exchange is pleased to announce that key clinical
data from several sources was presented at the Transcatheter Cardiovascular
Therapeutics 2005 (TCT) supporting the use of its proprietary antirestinosis
drug Biolimus A9(TM) and bioresorbable polymer coating on new drug-eluting
stent (DES) platforms. Perhaps most significantly, its licensee, Devax Inc.
reported positive results of its first human study using the Biolimus A9(TM)
drug / bioresorbable polymer coating technology combination at TCT. The new
Devax product is the first DES to be tested in humans with a design intended
specifically for the treatment of bifurcation lesions. Additional information
from the study is available on the Devax website at www.devax.net .
On the opening day of TCT, there were five separate ''live'' cases
broadcasted via satellite from clinical centres throughout Europe and South
America where patients suffering from coronary artery disease received DES
devices that incorporated Biosensors' Biolimus A9(TM) drug and bioresorbable
coating technology. Active discussions were held by clinicians throughout the
meeting about the potential safety and long term efficacy enhancements which
may result from the use of bioresorbable coatings on DES. Biosensors is the
first to obtain human study data on bioresorbable coating technology for DES
through its Future I and II trials, and subsequently in its STEALTH I trial
involving its latest product, the BioMatrix(TM) DES. BioMatrix(TM) has been
submitted for CE Mark regulatory approval in April of this year, and the
Company expects to receive approval to market the product in the first half of
A total of ten separate scientific presentations describing the clinical
and preclinical testing results of the Company's technology were presented at
TCT. ''Biosensors believes that the use of a bioresorbable polymer is a key
success factor for DES going forward as it potentially reduces concerns about
the possible long term negative effects of polymer coatings,'' said Mr. John
Shulze, Chief Technology Officer of Biosensors. ''We believe the results of
the Devax study, in a new, unmet clinical application, further support the
potential of bioresorbable coatings to improve the performance and safety of
DES,'' he added.
Biosensors also hosted a symposium at the TCT where leading cardiologists
presented results and commented on the use of its Biolimus A9(TM) drug and
bioresorbable polymer coatings on new DES platforms. The symposium was
presented by a panel of leading cardiologists including Dr. Hidehiko Honda of
Sendai Kohsei Hospital, Japan, Dr. David Holmes of Mayo Clinic, Rochester,
Minnesota, Dr. Martin Leon of the Cardiovascular Research Foundation, New
York, Dr. Alexandre Abizaid of Instituto Dante Paazzanese de Cardiologia, Sao
Paolo, Brazil, and Dr. Peter Fitzgerald of Stanford University, among others.
Entitled ''Optimizing Safe Treatment for Real World Patients -- an exposition
of Biolimus A9(TM)'', the symposium was attended by more than 200 medical
Apart from presentations of the Company's BioMatrix(TM) DES, the symposium
also focused on DES platforms involving the Devax bifurcation stents and a new
stent design from Xtent Inc. which will be used for treating long lesions and
complex cases. Devax and Xtent are companies who in-license the proprietary
drug and bioresorbable polymer technology from Biosensors.
Dr. Peter Fitzgerald, Professor of Research at Stanford University,
California presented Biosensors' clinical results from its STEALTH I clinical
trial for the BioMatrix(TM) DES. In a small group of patients receiving added
follow up at 12 months, Dr Fitzgerald indicated that the results of STEALTH I
were consistent with the positive 6-month clinical outcomes reported earlier
this year. ''It is truly exciting that Biosensors' bioresorbable polymer
technology will allow the drug-eluting stent to revert to a bare metal stent
after the drug is fully eluted. This is what all cardiologists are now
looking for in the face of heightening safety concerns surrounding stents with
durable polymer,'' stated Dr. Fitzgerald.
In going further to assess the BioMatrix(TM)'s performance in the real
world, Dr. Alexandre Abizaid of Instituto Dante Paazzanese de Cardiologia, Sao
Paolo, Brazil provided an insightful glimpse into the early findings of the
product within a ''real world'' population of 169 patients. In this study
which was done in a single centre in Thailand, the BioMatrix(TM) was found to
demonstrate a high device success rate of 98.3%, high procedural success rate
of 94.8%, and a target vessel revascularization rate of just 1.2% at 6 months
followup. In addition, Dr. Abizaid reported that the BioMatrix(TM) showed
zero incidence of thrombotic events and target lesion revascularization. Late
stent thrombosis has now been reported in several of the current generation
DES, raising concern by cardiologists attending TCT.
Devax's Principal Investigator Dr. Jeffrey W. Moses from Columbia
Presbyterian, New York drew attention to the ground-breaking safety and
efficacy results of the Devax stent in bifurcation lesions, which showed a
large reduction in parent branch restenosis of from between 5.7 - 11.5% using
alternative treatment methods to 5.6% using the Axxess Plus(TM) stent. Data
on side branch restenosis within the bifurcation lesion also showed similarly
encouraging results -- reducing those complications from between 11.1 - 21.8%
using alternative treatment methods to 7.9% using the Axxess Plus(TM) stent.
Dr. Gerckens of Siegburg Heart Center, Germany, who presented on behalf of
Prof. Dr. Eberhart Grube discussed the use of Biolimus A9(TM) on stents
designed for another new DES application using the Xtent Inc.'s platform,
Custom 1. Xtent's specialty stent platform technology is currently the only
DES designed for multi-lesion, multi-vessel, long lesion treatments.
About Biosensors International Group, Ltd.
Biosensors develops, manufactures and markets innovative medical devices
used in interventional cardiology and critical care procedures. Biosensors is
well-positioned to emerge as a leader in drug-eluting stents, an evolving
therapy that is rapidly gaining market share from traditional therapies such
as bare-metal stenting and open-heart surgery. Biosensors has internally
developed technology to address each component of a drug-eluting stent system,
including a stent, a stent delivery catheter, a bioresorbable polymer and a
proprietary anti-restenotic drug. It is pursuing two separate drug-eluting
stent programs, BioMatrix(TM) and AxxionTM, and has licensed aspects of its
drug-eluting stent technology to four companies.
Forward Looking Statements
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.