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BioMatrix drug-eluting stent system receives CE Mark approval

Biosensors International : 21 January, 2008  (New Product)
Biosensors International Group’s BioMatrix drug-eluting stent system has received CE Mark approval enabling commercialisation of the product in the European Union and the countries in Asia and Latin America that recognise the CE Mark.
The BioMatrix drug-eluting Stent system, developed internally by the company, consists of a 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, 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 non-exclusively in countries outside Japan excluding the USA. 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 that 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 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 programme 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.'

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 recognise the contributions of our people and the collaborative efforts of our licensees, especially Terumo, in achieving this milestone. This is truly an historic day for Biosensors.'
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