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 Cardi
|SOURCE Biosensors International Group, Ltd.|
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