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Thursday 21 October 2010

Biosensors Acquires Bifurcation-Stent Specialist Devax

Singapore 21 October 2010 – Biosensors International Group, Ltd (“Biosensors” or the “Company”, Bloomberg: BIG SP) today announced the acquisition of certain assets of Devax, Inc., a maker of specialty stents, for a total consideration of USD 5.7 million.


Headquartered in Irvine, California, US, Devax develops the AXXESS™ drug-eluting stent (DES) system designed specifically to treat the complex type of coronary artery disease that forms at the intersection of two vessels. Such bifurcation lesions occur in an estimated 15% to 25% of all patients undergoing percutaneous coronary interventions (PCI). Coronary bifurcations are prone to develop atherosclerotic plaque because of turbulent blood flow and high shear stress near the main branch and the adjacent side branch.

“The Devax AXXESS drug eluting stent is a natural complement to our existing product portfolio”, said Biosensors President and CEO Jeffrey B. Jump. “We have a large and growing base of clinical data demonstrating the unique benefits of our BioMatrix DES family of stents for treating main-branch lesions. The Devax AXXESS stent combines the same powerful combination of our proprietary Biolimus A9 drug and biodegradable polymer on a platform specifically designed for treating bifurcations safely, quickly and efficaciously.”

Treating bifurcation lesions is challenging, and existing provisional techniques that rely on standard main-branch stents have historically reported lower procedural success rates, higher procedural costs, longer post-procedure hospitalization periods, and higher rates of clinical and angiographic restenosis, as compared to treatment of lesions that do not involve bifurcations.
 
The AXXESS DES consists of a self-expanding, conically-shaped nitinol stent – designed to conform to the specific anatomy of bifurcations – coated with a biodegradable poly-lactic acid polymer eluting Biolimus A9®, a highly-lipophilic drug designed specifically for use in drug-eluting stent systems. The biodegradable polymer and Biolimus A9 were used in the AXXESS DES under license from Biosensors, and are the same components used in the Company’s BioMatrix™ range of drug eluting stents.


The AXXESS DES received CE Mark approval in August 2010, supported by the positive results from clinical trials designed to assess device safety and efficacy in treating coronary bifurcation lesions. One-year results from the DIVERGE trial – a prospective, multi-center study of 302 patients across 16 sites in Europe, Australia and New Zealand – were published in the Journal of the American College of Cardiology (JACC) in March 2009. The study demonstrated a low overall MACE rate (9.3%) and a low rate of late stent thrombosis (0.3%) in patients treated with the AXXESS DES. DIVERGE is the largest study conducted to date with a drug-eluting stent specifically designed for treating coronary bifurcation lesions.


The Company wishes to state that the purchase consideration of USD 5.7 million is from an existing cash resource and internally-generated funds. The acquisition is not expected to have a material impact on the consolidated earnings per share or net tangible assets of the Group’s financial year ending 31 March 2011.

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