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Aspirin Resistance Test Licensed to Corgenix Receives U.S. Patent Office Approval

Business Wire, August 21, 2006

DENVER -- U.S. Patent Office Grants Patent # 7,081,347 for Unique Methods for "Assessing Aspirin Resistance" and Risk of Cardiovascular Disease in Patients Taking Aspirin

Corgenix Medical Corporation (OTC BB: CONX), a worldwide developer and marketer of diagnostic test kits, has received notification of U.S. Patent Office approval for technology to which Corgenix and strategic partner Creative Clinical Concepts (CCC) hold exclusive worldwide licensing rights.

McMaster University (McMaster) of Hamilton, Ontario, is the original and sole owner of the aspirin resistance measurement method. Corgenix has developed the AspirinWorks(R) test kit, comprised of the components necessary to perform the quantitative measurement.

Based on results obtained from the Heart Outcomes Prevention Evaluation (HOPE) Study published in the March 25, 2002 issue of Circulation(1), the patent approval covers the ability of the AspirinWorks(R) Test Kit* to assess a patient's resistance to the anti-clotting effects of aspirin and also to assess the risk of a cardiovascular event (heart attack or stroke) in patients taking aspirin.

"This action by the U.S. Patent Office is a testament to our innovation and the strength of our strategic partnerships," said Douglass Simpson, Corgenix President and Chief Executive Officer. "Furthermore, it reinforces our strong expectations for this product following its recent submission for FDA pre-market clearance in the U.S."

The AspirinWorks(R) Test Kit - the Company's newest diagnostic product for cardiovascular disease - is a simple urine test that measures an individual's response to aspirin dosage and allows physicians to adjust the dosage or recommend alternative therapy. Recent reports indicate that up to 25 percent of individuals may be non-responsive to aspirin's benefits, and are more than three times more likely to die from heart disease.

Under terms of a license agreement with McMaster, Corgenix and CCC have exclusive worldwide rights to the proprietary technology owned by McMaster for the development, manufacturing and marketing of innovative diagnostic tests specific to the pathway by which aspirin acts on platelets. Corgenix recently submitted a Premarket Notification (510k) to the U.S. Food and Drug Administration (FDA) for the AspirinWorks(R) Test Kit.

The AspirinWorks(R) Test Kit is a quantitative enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids in the assessment of the response to aspirin. The kit was launched internationally in July at the 52nd Annual Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis held in Oslo, Norway.

The AspirinWorks(R) product was developed in conjunction with Corgenix' strategic partners, Creative Clinical Concepts (CCC), a Denver based biotechnology company, and Cayman Chemical Company (Cayman), an Ann Arbor, Michigan manufacturer of biochemical research products. Corgenix and CCC have previously announced collaboration with McMaster University (McMaster), Hamilton, Ontario.

The McMaster technology includes several patents pending in the United States, Canada and Europe, and has received notice of allowance of the first of the U.S. patent applications. In addition to licensing the McMaster technology, Corgenix also has a U.S. patent pending on the AspirinWorks(R) product.

*The AspirinWorks(R) Test Kit has not been cleared by the FDA for in vitro diagnostic use in the United States. In all countries where the use of this product has not been cleared, the product shall not be used for diagnostic use as the performance characteristics have not been established.

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases 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 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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