Healthcare Industry News: drug-eluting stent
News Release - January 18, 2008
Biosensors Receives CE Mark Approval for Its BioMatrix(R) Drug-Eluting Coronary Stent SystemSINGAPORE, January 18 (HSMN NewsFeed) -- International Group, Ltd. (Bloomberg: BIG SP, Company or Biosensors), today announced that 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 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®, 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.
BioMatrix offers the unique combination of an innovative anti-restenosic drug, Biolimus A9®, 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®, Axxion(TM), and BioMatrix® 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
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