Corgenix Submits 510(K) Filing for AtherOx(TM), a Next-Generation Predictive Cardiovascular Diagnostic Line.DENVER -- Corgenix Medical Corporation (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB: CONX) has submitted a 510(K) Premarket Notification submission to the Unites States Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for AtherOx(TM), its next-generation product group utilizing a patented technology to identify individuals at risk for developing atherosclerotic cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease . "Based on promising preclinical data, and wide acceptance of this next-generation predictive cardiovascular diagnostic line in Europe and Asia, we are extremely enthusiastic about the potential of AtherOx(TM) as a new marker in the evaluation of cardiovascular disease in the United States," said Corgenix Chief Executive Officer Douglass Simpson. "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." The AtherOx(TM) technology uses a combination of oxidized oxidized having been modified by the process of oxidation. oxidized cellulose see absorbable cellulose. Low-Density Lipoprotein low-density lipoprotein n. Abbr. LDL A lipoprotein that contains relatively high amounts of cholesterol and is associated with an increased risk of atherosclerosis and coronary artery disease. (oxLDL, a pro-atherogenic form of cholesterol) and B2GPI (Graphical Programming Interface) A graphics language in OS/2 Presentation Manager. It is a derivative of the GDDM mainframe interface and includes Bezier curves. , a plasma protein plasma protein n. Any of the various dissolved proteins of blood plasma, including antibodies and blood-clotting proteins, that act by holding fluid in blood vessels by osmosis. that participates in thrombosis. Although oxLDL has been implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in cardiovascular disease, clinical data demonstrates that the determination of AtherOx(TM), rather than of oxLDL alone, is a more accurate assessment of the risk of progressive atherosclerotic cardiovascular disease. Corgenix licensed the proprietary AtherOx(TM) technology in 2002 from Professor Eiji Matsuura, Ph.D., of Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences in Okayama, Japan. Led by Chief Medical Officer Dr. Luis R. Lopez, Corgenix has incorporated this technology into several new diagnostic products, conducting multiple studies that further validate the impressive preclinical data generated by Professor Matsuura. In continuing its work with AtherOx(TM), Corgenix has also appointed Dr. Greg Svanas as the Company's new Project Director for Research and Development in Immunology, including AtherOx(TM). Dr. Svanas comes to Corgenix from Inverness Medical - Biostar, where he served as Associate Director of Research and Development. Dr. Svanas has extensive experience with assay development on multiple platforms in a GMP/ISO environment, and is an expert in infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. , cardiac and other immunologic markers. Detailed clinical data on the AtherOx(TM) technology, as well as several published peer-reviewed articles and other news pieces, are available on the Company Web site, www.corgenix.com. About Corgenix Medical Corporation Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases vascular diseases, n.pl diseases of the peripheral circulatory system. and bone and joint disorders. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience advancing products through the FDA process. More information is available at www.corgenix.com. Statements in this press release that are not strictly historical facts are "forward looking" statements (identified by the words "believe", "estimate", "project", "expect" or similar expressions) within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company's products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the company does not undertake any obligation to publicly update or revise any forward-looking statements. |
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