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 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 professionals.
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.
Media Contact Information Biosensors International Group Ms Tina Lim, Executive, Corporate Communications Tel: +65-6213-5712 Email: tlc.lim@biosensors.com For investor related enquiries, please write to ir@biosensors.com WeR1 Consultants Pte Ltd Mona Leong Senior Consultant Tel: +65-6737-4844 / Hp: +65-9187-4449 Email: monaleong@wer1.net Allen & Caron Inc. Matt Clawson Executive Vice President, Investor Relations Tel: +1-949-474-4300 Email: matt@allencaron.com
Biosensors International Group, Ltd.CONTACT: Ms Tina Lim of Biosensors, +65-6213-5712, ortlc.lim@biosensors.com; or Mona Leong of WeR1 Consultants Pte Ltd forBiosensors, +65-6737-4844, or +65-9187-4449, monaleong@wer1.net; MattClawson of Allen & Caron Inc. for Biosensors +1-949-474-4300, ormatt@allencaron.com
Web site: http://www.devax.net/
