Will BioMatrix provide a valuable alternative to the drug-eluting stents currently available to interventional cardiologists? Is the three-year follow-up data released at the Transcatheter Cardiovascular Therapeutics Conference showing BioMatrix’s superior results in terms of safety and clinical effectiveness? Will the increasing complexity of worldwide regulatory requirements make it more difficult in the future to introduce competitive new technologies into the marketplace?
…the Company has received Conformite Europeenne (“CE”) Mark approval for its BioMatrix® 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 drugeluting stent system, developed internally by the Company, consists of a unique drugeluting stent that incorporates a biodegradable polymer and the Company’s proprietary drug, Biolimus A9, 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™ 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 nonexclusively 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 drugeluting stent system required for Japanese regulatory approvals…
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