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Pre-clinical Data Show OrbusNeich's Combo Bio-engineered Sirolimus Eluting Stent May Offer Advantages to Current Drug Eluting Stent Technologies
Date:9/23/2009

SAN FRANCISCO, Sept. 23 /PRNewswire/ -- OrbusNeich announced today that pre-clinical data involving porcine coronary models demonstrate that the company's Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) may offer advantages to the Cypher(R) sirolimus eluting stent and the XIENCE(TM) V everolimus eluting stent.

Specifically, histological and optical coherence tomography (OCT) data out to 28 days show that the Combo Stent had lower neointimal hyperplasia and stenosis, as well as lower inflammation and fewer giant cells on the stent struts. The data were presented by Juan F. Granada, M.D., medical director of the Skirball Center for Cardiovascular Research and assistant professor at Columbia University Medical Center, New York, at the Transcatheter Cardiovascular Therapeutics symposium, TCT 2009, in San Francisco.

"We are very pleased with the pre-clinical outcomes of OrbusNeich's innovative Combo Stent," said Dr. Granada. "The biological effects observed with the Combo Stent could potentially translate into a clinical advantage by improving vascular healing while maintaining effective control of neointima proliferation, enhancing the safety profile of current drug eluting stents by harnessing the additive effect of EPC recruitment."

Endothelial coverage and functionality for the Combo Stent was demonstrated to be similar to the Genous(TM) Bio-engineered R stent(TM) at 14 days in the porcine model and revealed a 50 percent greater endothelialization rate than Cypher sirolimus-eluting stent as measured by visual microscopy and endothelial cell marker expression.

The Combo Stent combines the endothelial progenitor cell (EPC) capture technology found in OrbusNeich's Genous Bio-engineered R stent for accelerated healing with abluminal low dose sirolimus sustained drug elution for the control of neointimal proliferation.

Stephen M. Rowland, Ph.D., OrbusNeich's vice president of research and development, said, "Combo will enable us to expand on the benefits offered by our Genous technology. The results of this dual coating technology represent the culmination of our engineering efforts to achieve a partitioned effect on the body's response to stent injury. Our collaborative efforts with world class experts have paved the way for our soon to be initiated human clinical trial."

About Genous

Genous is OrbusNeich's patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

OrbusNeich's Genous Bio-engineered R stent has been commercially available in over 60 countries since 2005. The Genous stent has been proven as a safe, effective alternative to drug-eluting stents and is supported by data from more than 5,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.

About OrbusNeich

OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous Bio-engineered R stent, as well as stents, balloons and guiding catheters marketed under the names of Blazer(TM), R stent, Scoreflex(TM), SafeCut(TM), Sapphire(TM), Sapphire NC, Avita(TM), Avita HP and Lumina(TM). OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.

Editor's Notes: OrbusNeich will display the Genous Bio-engineered R stent and other products at booth No. 330 at TCT 2009. Product images are available on request.


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