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We are well-positioned to emerge as a leader in drug-eluting stents ("DES"), an evolving therapy that is rapidly gaining market share from traditional cardiovascular therapies. Since 1990, Biosensors has manufactured and marketed critical care catheter systems and related devices used during heart surgery and intensive care treatment and monitoring. In 2000, we entered the interventional cardiology market with our proprietary coronary bare-metal stent and accompanying stent delivery balloon catheter system. In the same year, we further expanded our product line to include angioplasty balloons and catheters. Most recently, we made our entry into the US$6b global DES market with the introduction of our flagship BioMatrix®and Axxion™ product lines. Our BioMatrix DES is unique in that it uses a proprietary biodegradable polymer and anti-restenotic drug, Biolimus A9®. Our Axxion DES is a polymer-free system in which the drug is directly coated on the stent over a layer of glycocalix, a substrate designed to improve biocompatibility of the metal stent surface after the drug is released. At recent international conferences, leading cardiologists have highlighted the need for a safer DES with a shorter duration of polymer exposure in the body and the use of less toxic drugs which promote rather than delay the healing process. Cardiologists have commented that BioMatrix and Axxion DES which have no polymer remaining in the body after the drug elution is complete offer good alternatives to currently-available DES. We received CE Mark regulatory approval for Axxion in July 2005, and have submitted our BioMatrix DES for CE Mark regulatory approval. We have also licensed aspects of our proprietary DES technology to third parties, including Terumo Corporation, Guidant Corporation and specialty-stent providers, Devax, Inc. and Xtent, Inc. Biosensors affiliated companies maintain offices in Newport Beach, California, The Netherlands, Germany, Switzerland, Singapore, and Japan. Our interventional products are currently being manufactured in Singapore and The Netherlands. |