2014

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

    SINGAPORE, Jan. 18 /PRNewswire/ -- International Group, Ltd.
 (Bloomberg: BIG SP, Company or Biosensors), today announced that the
 Company has received Conformite Europeenne (CE) Mark approval for its
 BioMatrix(R) drug-eluting stent system, enabling commercialization of this
 product in the European Union and the countries in Asia and Latin America
 that recognize the CE Mark. The BioMatrix drug-eluting stent system,
 developed internally by the Company, consists of a unique drug-eluting
 stent that incorporates a biodegradable polymer and the Company's
 proprietary drug, Biolimus A9(R), which inhibits restenosis, or
 re-narrowing of the arteries, following stent implantation.
 
     Terumo Corporation (Terumo), a licensee of Biosensors' BioMatrix
 technology, also announced CE Mark approval for its NOBORI(TM) drug-eluting
 stent system. In October 2003, Biosensors and Terumo entered into a
 licensing agreement that granted Terumo the rights to sell the NOBORI
 drug-eluting stent system exclusively in Japan and non-exclusively in
 countries outside Japan excluding the United States. Under this agreement,
 Terumo will share a portion of the revenues from the sales of NOBORI with
 Biosensors. In May 2007, Terumo commenced the clinical trial of the NOBORI
 drug-eluting stent system required for Japanese regulatory approvals.
 
     "We are very pleased to have received CE Mark approval for our
 BioMatrix stent and will immediately implement our strategy to make this
 product available in the approved markets. Our growth potential in these
 markets is very strong, as BioMatrix and NOBORI will be the only
 drug-eluting stents currently available which incorporate a biodegradable
 polymer coating together with an immunosuppressive drug. Positive clinical
 data position the BioMatrix stent system to be a potential break-through
 product for patients and physicians," stated Mr. Yoh-Chie Lu, Chairman and
 Chief Executive Officer.
 
     Professor Eberhard Grube, Chief of Angiology and Cardiology at Siegburg
 Heart Center in Germany and a principal investigator for the BioMatrix
 clinical trial program commented, "BioMatrix will provide a valuable
 alternative to the drug-eluting stents currently available to
 interventional cardiologists. The results from the BioMatrix clinical
 trials have been consistently very positive and promising. The three-year
 follow-up data released at the Transcatheter Cardiovascular Therapeutics
 Conference last year continued to demonstrate BioMatrix's superior results
 in terms of safety and clinical effectiveness. The BioMatrix drug-eluting
 stent has shown excellent procedural performance and outcome
 characteristics."
 
     Mr. Lu added: "We are also pleased with the timing of this approval, as
 the increasing complexity of worldwide regulatory requirements will make it
 even more difficult to introduce new technologies into the marketplace. We
 plan to commence a staged launch of BioMatrix commencing 1 April 2008. The
 initial stage will be to introduce BioMatrix through our existing
 distribution channels. We will expand these channels to increase
 geographical coverage during the first half of our fiscal year beginning in
 April 2008 and plan a significant ramp up in sales over the second half of
 our fiscal year.
 
     "Many years of effort devoted to developing the BioMatrix drug-eluting
 stent system have been validated by this approval. We would like to take
 this opportunity to recognize the contributions of our people and the
 collaborative efforts of our licensees, especially Terumo Corporation, in
 achieving this milestone. This is truly an historic day for Biosensors,"
 concluded Mr. Lu.
 
     About BioMatrix
 
     BioMatrix offers the unique combination of an innovative
 anti-restenosic drug, Biolimus A9(R), a biodegradable polymer, and advanced
 stent design.
 
     Biolimus A9 was designed specifically to maximize stent efficacy. In
 addition to effective immunosuppressive and anti-inflammatory properties,
 the drug has a higher lipophilic and hydrophobic profile than other drugs
 in its class, enabling the drug to be rapidly absorbed into tissue, with
 reduced systemic exposure.
 
     The PLA polymer fully degrades into water and carbon dioxide as the
 drug is released, ultimately leaving in place a biocompatible stent
 surface. The polymer is coated onto the outer (abluminal) side of the stent
 only, enabling the drug to be released to targeted tissue. The
 internally-developed stent used in the BioMatrix system is designed for
 increased flexibility in delivery.
 
     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
 biodegradable polymer and a proprietary anti-restenosis drug. It is
 pursuing three separate drug-eluting stent programs, BioMatrix(R),
 Axxion(TM), and BioMatrix(R) Freedom(TM), a polymer-free drug-eluting
 stent, 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.
 
 
 

SOURCE Biosensors International Group, Ltd.

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