New Clinical Data Presented at Transcatheter Cardiovascular Therapeutics 2005 Supports Use of Biolimus A9(TM) and Bioresorbable Coating on New DES Platforms

Oct 26, 2005, 01:00 ET from Biosensors International Group, Ltd.

    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 .
     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
 calendar 2006.
     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.
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 looking terminology, such as ''may,'' ''will,'' ''expect,'' ''intend,''
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 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.