Friday, January 18, 2008

Biosensors Receives CE Mark Approval for Its BioMatrix(R) Drug-Eluting

SINGAPORE, Jan. 18 /PRNewswire/ -- International Group, Ltd.(Bloomberg: BIG SP, Company or Biosensors), today announced that the Companyhas received Conformite Europeenne (CE) Mark approval for its BioMatrix(R)drug-eluting stent system, enabling commercialization of this product in theEuropean Union and the countries in Asia and Latin America that recognize theCE Mark.

The BioMatrix drug-eluting stent system, developed internally by theCompany, consists of a unique drug-eluting stent that incorporates abiodegradable polymer and the Company's proprietary drug, Biolimus A9(R),which inhibits restenosis, or re-narrowing of the arteries, following stentimplantation.

Terumo Corporation (Terumo), a licensee of Biosensors' BioMatrixtechnology, also announced CE Mark approval for its NOBORI(TM) drug-elutingstent system. In October 2003, Biosensors and Terumo entered into a licensingagreement that granted Terumo the rights to sell the NOBORI drug-eluting stentsystem exclusively in Japan and non-exclusively in countries outside Japanexcluding the United States.

Under this agreement, Terumo will share aportion of the revenues from the sales of NOBORI with Biosensors. In May2007, Terumo commenced the clinical trial of the NOBORI drug-eluting stentsystem required for Japanese regulatory approvals.

"We are very pleased to have received CE Mark approval for our BioMatrixstent and will immediately implement our strategy to make this productavailable in the approved markets. Our growth potential in these markets isvery strong, as BioMatrix and NOBORI will be the only drug-eluting stentscurrently available which incorporate a biodegradable polymer coating togetherwith an immunosuppressive drug. Positive clinical data position the BioMatrixstent system to be a potential break-through product for patients andphysicians," stated Mr. Yoh-Chie Lu, Chairman and Chief Executive Officer.

Professor Eberhard Grube, Chief of Angiology and Cardiology at SiegburgHeart Center in Germany and a principal investigator for the BioMatrixclinical trial program commented, "BioMatrix will provide a valuablealternative to the drug-eluting stents currently available to interventionalcardiologists. The results from the BioMatrix clinical trials have beenconsistently very positive and promising. The three-year follow-up datareleased at the Transcatheter Cardiovascular Therapeutics Conference last yearcontinued to demonstrate BioMatrix's superior results in terms of safety andclinical effectiveness. The BioMatrix drug-eluting stent has shown excellentprocedural performance and outcome characteristics."

Mr. Lu added: "We are also pleased with the timing of this approval, asthe increasing complexity of worldwide regulatory requirements will make iteven more difficult to introduce new technologies into the marketplace. Weplan to commence a staged launch of BioMatrix commencing 1 April 2008. Theinitial stage will be to introduce BioMatrix through our existing distributionchannels. We will expand these channels to increase geographical coverageduring the first half of our fiscal year beginning in April 2008 and plan asignificant ramp up in sales over the second half of our fiscal year."

Many years of effort devoted to developing the BioMatrix drug-elutingstent system have been validated by this approval. We would like to take thisopportunity to recognize the contributions of our people and the collaborativeefforts of our licensees, especially Terumo Corporation, in achieving thismilestone. This is truly an historic day for Biosensors," concluded Mr. Lu.

About BioMatrix

BioMatrix offers the unique combination of an innovative anti-restenosicdrug, Biolimus A9(R), a biodegradable polymer, and advanced stent design.

Biolimus A9 was designed specifically to maximize stent efficacy.

Inaddition to effective immunosuppressive and anti-inflammatory properties, thedrug has a higher lipophilic and hydrophobic profile than other drugs in itsclass, enabling the drug to be rapidly absorbed into tissue, with reducedsystemic exposure.

The PLA polymer fully degrades into water and carbon dioxide as the drugis released, ultimately leaving in place a biocompatible stent surface.

Thepolymer is coated onto the outer (abluminal) side of the stent only, enablingthe drug to be released to targeted tissue. The internally-developed stentused in the BioMatrix system is designed for increased flexibility indelivery.

About Biosensors International Group, Ltd

Biosensors develops, manufactures and markets innovative medical devicesused in interventional cardiology and critical care procedures. Biosensors iswell-positioned to emerge as a leader in drug-eluting stents, an evolvingtherapy that is rapidly gaining market share from traditional therapies suchas bare-metal stenting and open-heart surgery.

Biosensors has internallydeveloped technology to address each component of a drug-eluting stent system,including a stent, a stent delivery catheter, a biodegradable polymer and aproprietary anti-restenosis drug. It is pursuing three separate drug-elutingstent programs, BioMatrix(R), Axxion(TM), and BioMatrix(R) Freedom(TM), apolymer-free drug-eluting stent, and has licensed aspects of its drug-elutingstent technology to four companies.

Forward Looking Statements

Certain statements herein include forward-looking statements within themeaning of the U.S. Private Securities Litigation Reform Act of 1995.Forward-looking statements generally can be identified by the use offorward-looking terminology, such as "may," "will," "expect," "intend,""estimate," "anticipate," "believe," "project" or "continue" or the negativethereof or other similar words.

All forward-looking statements involve risksand uncertainties, including, but not limited to, customer acceptance andmarket share gains, competition from companies that have greater financialresources; introduction of new products into the marketplace by competitors;successful product development; dependence on significant customers; theability to recruit and retain quality employees as Biosensors grows; andeconomic and political conditions globally. Actual results may differmaterially from those discussed in, or implied by, the forward-lookingstatements. The forward-looking statements speak only as of the date of thisrelease and Biosensors assumes no duty to update them to reflect new, changingor unanticipated events or circumstances.

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