Corgenix receives third U.S. patent on AtherOx technology

Corgenix Medical Corporation has received notification of U.S. Patent Office approval for technology to which Corgenix holds exclusive worldwide licensing rights outside of Japan.

The technology is incorporated in the Company's AtherOx product group, a next-generation technology to identify individuals at risk for developing atherosclerotic cardiovascular disease.

U.S. Patent # 7,422,864 was issued September 9, 2008. The patent Method for Measuring Oxidized LDL-CRP Complex and Measurement Kit, describes the binding of oxidized low-density lipoprotein (oxLDL) with C-reactive protein (CRP) resulting in oxLDL/CRP (CRP-AtherOx) complex formation, and the immunoassay method for measuring these complexes in blood. CRP is an inflammatory protein that has been associated with risk of cardiovascular disease. High levels of CRP can be found in many inflammatory and infectious disorders, but oxLDL/CRP complexes were more specific and predictive of atherosclerotic cardiovascular disease (Tabuchi et al. J Lipid Res 2007; 48:768-781).

The latest patent adds to previous U.S. patents (# 5,900,359 issued May 4, 1999, Method for Determination of Oxidized Lipoproteins and Use Thereof, and # 7,160,733 issued January 9, 2007, Ligand Specific to B2-glycoprotein I and Use Thereof. These patents described the specific interaction of B2-glycoprotein I with the oxidized form of low-density lipoprotein (oxLDL) leading to the formation of oxLDL/B2-glycoprotein I complexes (AtherOx). This interaction does not occur with the native or non-oxidized form of LDL. An immunoassay for the detection of the complexes was described which provides the basis for the AtherOx test kits.

Douglass Simpson, President and CEO of Corgenix said, "We are very pleased to announce this important addition to our IP portfolio. We have one product already cleared by the FDA and several products in the later stages of the development pipeline with FDA submission expected in the next year or so. Since cardiovascular disease is one of the world's leading causes of death, the early detection of atherosclerosis has become increasingly important, and we are optimistic about our ability to serve this significant market."

In all countries where the use of products employing this technology have not been cleared, the products shall not be used for diagnostic use as the performance characteristics have not been established.

The AtherOx technology utilizes oxidized low-density-lipoprotein (oxLDL) complexed with the plasma protein B2GPI. Although oxLDL has been implicated in cardiovascular disease, according to results published in the Annals of N.Y. Academy of Science (2007), determination of oxLDL/.2GPI complexes, rather than oxLDL alone, may be a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease in individuals with systemic lupus erythematosus and lupus-like disorders. Corgenix licensed this technology in 2002, and is developing additional products utilizing this unique platform. In addition to the three U.S. patents which have been issued, several others are pending.