IRVINE, Calif. & EINDHOVEN, Netherlands--(BUSINESS WIRE)--Jan. 8, 2004--Devax and Occam International B.V., an affiliate of Biosensors International, jointly announced today that they have signed a license agreement to incorporate Occam's proprietary coating and drug Biolimus A9 on the Devax Axxess Bifurcation Stent platform. Under terms of the license, Occam will provide coating services to Devax, and will receive milestone payments based on the success of clinical trials and a royalty on Devax's sale of the product.
The Devax Axxess Bifurcation Stent system is specifically designed for the treatment of lesions at the bifurcations of the coronary vasculature. The uncoated Axxess stent received CE Mark approval in Europe in August 2003 and will be available outside the United States in the first quarter of 2004.
The drug-eluting stent is designed to reverse the narrowing of coronary arteries that is the hallmark of many cases of coronary artery disease. Implanted in an artery following balloon angioplasty, it uses the strength of its cylindrical metal mesh wall to maintain restored blood flow. Following implantation, it gradually releases ("elutes") into surrounding tissues an anti-proliferative drug called Biolimus A9.
Biolimus A9 is formulated to inhibit excessive tissue formation around the stent following implantation, a common side effect called restenosis which often threatens to reverse the clinical benefits of the angioplasty and stent implantation procedures. Biolimus A9 is proprietary to Occam and its parent, Sun Biomedical, Ltd., and is being evaluated in clinical trials of its MATRIX(TM) stent in Europe, code-named the STEALTH I trial.
"This license is an important milestone for Devax," said Jeff Thiel, President and CEO of Devax. "We have proven the clinical utility of the Axxess technology for the treatment of bifurcation lesions in coronary arteries. By incorporating the Occam coating and drug, we will have a stent system that provides the interventional cardiologist with a breakthrough device for the treatment of this difficult patient population."
"We are excited to be working together with Devax, and this gives us the opportunity to be the first company in the stent industry to apply our potent antiproliferative drug, Biolimus A9, on the difficult class of bifurcation lesions," stated Yoh-Chie Lu, President and CEO of Biosensors International. "Bifurcation lesions represent approximately 30% of all cases, and typically have a much higher restenosis rate than lesions in non-branched vessels. We feel it is time to bring the benefits of drug-eluting stent technology to those patients having these more difficult-to-treat lesions such as bifurcations. Devax offers a highly innovative stent platform which can benefit from the drug-eluting stent coating technology we have developed."
Devax is a private, closely-held, emerging medical device company, which is developing unique stent and stent delivery systems for the treatment of bifurcated coronary, carotid and peripheral vascular applications.
Occam and its affiliated group of companies focuses its research in the fields of new drug discovery, stent design and local drug delivery coating development for interventional cardiology markets worldwide. Occam and Biosensors International are both subsidiaries of Sun Biomedical Ltd., and seek to become a leading group of companies specializing in cardiovascular technology.
For more information, please visit http://www.biosensors.com.sg.
Biosensors International USA 949-553-8300 InvestorInfo@Biosensors-usa.com or Devax Jeff Thiel, 949-461-0450 x23 or Media Relations: Coffin Communications Group Sean Collins, 818-789-0100 or 310-497-9205 Valerie Bent, 702-270-9696.
Source: Biosensors International