Corgenix Transfers to ORGENTEC Exclusive Worldwide Distribution Rights. Effective July 1st

DENVERJune 3, 2015 —We are pleased to announce that ORGENTEC Diagnostika has finalized its acquisition of Corgenix Inc.

As a result, the Corgenix product range has transferred to ORGENTEC now holding the exclusive worldwide distribution rights. Effective July 1st, please direct orders and inquiries for Corgenix products to ORGENTEC who will be happy to handle your inquiries (or refer you to the appointed local distributor, if applicable). Be assured that we will do our best to keep supply seamless. ORGENTEC and Corgenix will work hard to earn your trust and loyalty.
If you have any questions, please contact us. Your ORGENTEC and Corgenix International Commercial Team

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Corgenix Joins Strategic Partners, Presents Science at AACC Meeting and Clinical Lab Expo 2014

Corgenix to exhibit AspirinWorksÒ Test, present abstracts, including “best abstract” for Ebola research and first-ever oral presentation.

DENVER — July 22, 2014 — Corgenix Medical Corporation (OTC BB: CONX.OB), a worldwide developer and marketer of diagnostic test kits, will collaborate with strategic partners and also present several scientific abstracts at the American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo 2014 in Chicago.

Corgenix will exhibit its AspirinWorks® (11dhTxB2) Test at AACC July 29 to July 31, 2014, in booth No. 3735. Also featured will be the SkyLAB752™ instrument from strategic partner AXA Diagnostics; SkyLAB752 is the fastest automated ELISA instrument for processing the Corgenix AspirinWorks assay. Corgenix will have an additional presence in strategic partner ELITech Group’s booth No. 741 where several Corgenix products will be on display, including the AspirinWorks/11dhTxB2 and Hyaluronic Acid Test Kits.

Among its five scientific presentations, Corgenix has been awarded Best Annual Meeting Abstract for AACC 2014 in the Critical and Point of Care Testing Division for Infectious Disease poster B-068 titled “Development of a Point-of-Care Diagnostic for Ebola and Sudan Virus Detection.” The company is also presenting an oral abstract of Clinical Studies/Outcomes poster A-143 titled “Suspected Lassa Fever (LF) Case Outcomes: A Comparison to a Non-Febrile Population in Sierra Leone.” The oral abstract will be presented at 11:30 a.m. during the Thursday, July 31, 2014, morning symposia titled “Infected: Innovative Ideas in Laboratory Medicine for Acute and Chronic Infections.”

The three additional Corgenix poster abstracts to be presented during AACC 2014 are 1) Cardiac Markers poster B-356: “An Immunoturbidimetric Assay for the Detection of Thromboxane Metabolites in Urine;” 2) Hematology/Coagulation poster A-296: “A Dual Monoclonal Antibody Chemiluminescent ELISA for the Detection of Hepcidin-25;” and 3) Infectious Disease poster

B-079: “An Immunoturbidimetric Assay for Hyaluronic Acid.”

Corgenix representatives will be available during the conference to answer questions about the AspirinWorks Test and other products, including its diagnostic kits for immunology disorders, vascular diseases, and bone and joint disorders.

AspirinWorks is a simple, non-invasive lab test performed on a urine specimen, which helps doctors accurately determine aspirin effect in apparently healthy individuals by measuring levels of 11-dehydro thromboxane B2 (11dhTxB2). High levels of 11dhTxB2, a metabolite of thromboxane — the target of aspirin therapy — heighten the risk of cardiovascular events, including stroke, myocardial infarction and cardiac death. The goal of aspirin therapy is to reduce levels of thromboxane in the blood, decreasing platelet stickiness and therefore reducing the chance of forming a blood clot.

Unlike other functional platelet tests that require freshly drawn blood that must be evaluated in five hours, the AspirinWorks Test is performed on a random urine sample that can be obtained in any doctor’s office. Physicians and laboratories interested in ordering the test can call 1-800-729-5661 x180, or email info@aspirinworks.com. More information is also available at www.aspirinworks.com.

The Hyaluronic Acid Test Kit has not been cleared or approved for diagnostic use in the United States by the U.S. Food and Drug Administration. However, it is CE marked for diagnostic use in the European Union.

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. 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 in product submissions to the FDA and other worldwide regulatory authorities. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com (Corporate website) and www.corgenix.net (Contract Services website).

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.

 

Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP and CFO

Phone: 303-453-8903

Email: wcritchfield@corgenix.com

 

Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230

Email: dan@armadamedical.com

Corgenix Announces CE Mark Notification for TxBCardio™ Assay

TxBCardio is the first automated assay available globally on clinical chemistry systems or urinary assessment of the thromboxane biomarker (11dhTxB2) for aspirin effect 

DENVER — May 15, 2014 — Corgenix Medical Corporation (OTC BB: CONX.OB) announced in collaboration with Randox Laboratories that Randox has been granted CE Mark notification for its TxBCardio™ Assay. The TxBCardio test measures urinary levels of the thromboxane metabolite 11dhTxB2 to determine aspirin effect in apparently healthy individuals. CE mark designation enables commercial marketing and distribution of the product in Europe.

The TxBCardio automated immunoturbidimetric (IT) assay format enables testing for urinary 11dhTxB2, the thromboxane metabolite measured by the AspirinWorks™ Test (ELISA assay), to be run on clinical chemistry platforms for higher-volume laboratories and in hospitals. The AspirinWorks Test is a simple urine test that measures levels of 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals. The AspirinWorks Test was FDA-cleared in the U.S. in 2007; the TxBCardio brand was established to better emphasize the importance of the thromboxane biomarker while expanding into new products and technologies. The AspirinWorks ELISA assay continues to be sold worldwide.

“Achieving CE Mark is a significant milestone in our collaborative development efforts with Randox for thromboxane testing,” said Douglass Simpson, Corgenix President and CEO. “We’re also moving forward with our strategic partner and master distributor, the ELITech Group, to expand global coverage of this new assay and broaden application onto additional platforms.”

The TxBCardio assay will be manufactured at Randox Laboratories in the United Kingdom. Both Corgenix Medical and Randox Laboratories will be selling the new test worldwide under the TxBCardio brand name.

The safety and efficacy of the TxBCardio assay has not yet been evaluated by the FDA and therefore is not cleared for clinical diagnostic use in the United States.

 

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. 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 in product submissions to the FDA and other worldwide regulatory authorities. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com (Corporate website) and www.corgenix.net (Contract Services website).

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.

 

Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP Operations and Finance and CFO

Phone: 303-453-8903

Email: wcritchfield@corgenix.com

 

Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230

Email: dan@armadamedical.com

Corgenix Announces Filing of 510(k) Premarket Notification for FDA Clearance of TxBCardio™ Assay

Filing is first under Corgenix Medical-Randox Laboratories co-development agreement

DENVER — December 16,  2013 — Corgenix Medical Corporation (OTC BB: CONX.OB) announced today that in collaboration with Randox Laboratories, the first premarket notification has been filed with the U.S. Food and Drug Administration pursuant to Section 510(k) of the U.S. Federal Food, Drug and Cosmetic Act for the TxBCardio™ immunoturbidimetric (IT) assay.

The Company stated that the TxBCardio brand was established to better emphasize the importance of Thromboxane. Clinical research continues to show that thromboxane metabolites are relevant in several disease states beyond just aspirin effect. The TxBCardio brand will allow the Company to continue the focus on Thromboxane while expanding into new products and technologies.

The filing is based on TxBCardio’s substantial equivalence to the Corgenix AspirinWorks ELISA assay, a simple urine test that is FDA cleared to measure levels of 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals. Co-development of the TxBCardio IT assay enables the 11dhTxB2 AspirinWorks assay to be run on clinical chemistry platforms for higher-volume laboratories and in hospitals.

“This 510(k) application marks a substantial step forward in our collaborative development efforts for thromboxane testing,” said Douglass Simpson, Corgenix President and CEO. “Along with our strategic partner and master distributor the ELITech Group, we intend to expand the application of this new assay onto additional platforms over the next 18-24 months.” 

The assay would be manufactured at Randox Laboratories in the United Kingdom. Both Corgenix Medical and Randox Laboratories would be selling the new test worldwide under the TxBCardio brand name.   

The safety and efficacy of the TxBCardio assay has not yet been evaluated by the FDA.

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. 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 in product submissions to the FDA and other worldwide regulatory authorities. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. 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.

 

Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP Operations and Finance and CFO

Phone: 303-453-8903

Email: wcritchfield@corgenix.com

 

Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230

Email: dan@armadamedical.com

Study: Aspirin Ineffective in 20 Percent of Heart Disease Patients

Corgenix Medical Corporation, developer of the AspirinWorksÒ Test, says study highlights importance of measuring thromboxane biomarker to determine aspirin response

DENVER — November 04, 2013A major new study conducted in Ireland found that 20 percent of patients with established heart disease were not adequately protected by aspirin. Corgenix Medical Corporation, developers of the AspirinWorksÒ Test for aspirin effect, said the study adds more evidence to the importance of accurately measuring aspirin response by measuring levels of the biomarker thromboxane.

“These and other major trials have established that the failure of patients to respond to the intended beneficial effect of aspirin may be a key factor in putting millions at increased risk of heart attack and stroke,” said Douglass Simpson, President and CEO of Corgenix. “The AspirinWorks Test accurately measures thromboxane levels in healthy individuals, allowing physicians to identify its potential interference with aspirin’s ability to help reduce heart attack and stroke risk.”

The Irish study conducted by the Irish Heart Foundation’s National Cardiovascular and Stroke Research Network (NCSRN) prospectively evaluated aspirin response in 700 patients with stable coronary artery disease by measuring thromboxane levels. Results showed that age, high blood pressure, weight and alcohol consumption were significant risk factors for a poor response to aspirin. Full study resultswere presented at the 64th Irish Cardiac Society Annual Scientific Meeting in Killarney, Ireland.

AspirinWorks is the only U.S. FDA-cleared test that measures the urinary biomarker 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals. The test identifies those individuals who have elevated thromboxane levels despite taking a daily aspirin dose, with studies showing up to 25 percent of individuals not seeing the expected beneficial effects of aspirin. AspirinWorks is used by thousands of physicians to test and guide treatment for hundreds of thousands of patients each year worldwide.

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. 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 in product submissions to the FDA and other worldwide regulatory authorities. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com.

 

Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP and CFO

Phone: 303-453-8903

Email: wcritchfield@corgenix.com

 

Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230

Email: dan@armadamedical.com

Corgenix Teams Up with Strategic Partners at AACC Clinical Lab Expo 2013

Corgenix to exhibit AspirinWorks Test and SkyLAB752 high-throughput automated platform

DENVER — July 17, 2013Corgenix Medical Corporation (OTC BB: CONX), a worldwide developer and marketer of diagnostic test kits, will collaborate with strategic partners ELITech Group and AXA Diagnostics at the AACC Clinical Lab Expo 2013 in Houston, Texas.

Corgenix will exhibit its AspirinWorks® (11dhTxB2) Test at AACC July 30 – August 1 in booth No. 3009.

Also on display in the Corgenix booth will be the SkyLAB752™ instrument from strategic partner AXA Diagnostics. The Corgenix team will present the new, high-throughput ELISA automated platform, which can process up to 7 microplates simultaneously. The SkyLAB752 is the fastest automated instrument for processing the Corgenix AspirinWorks assay, due to its ability to process up to 384 samples in a single run.

Additionally, Corgenix will have a presence in strategic partner ELITech Group’s booth No. 4707 and 4805, where several Corgenix products will be on display, including the AspirinWorks/11dhTxB2 and Hyaluronic Acid Test Kits. In 2010, the two companies entered into a formal strategic alliance to co-develop new diagnostic tests. The alliance includes an ELITech Group investment in Corgenix and the expansion of Corgenix’ distribution network for its test kits. The Hyaluronic Acid Test Kit has not been cleared or approved for diagnostic use in the Untied States by the US Food and Drug Administration. However, it is CE marked for diagnostic use in the EU.

Corgenix representatives will be available during the conference to answer questions about the AspirinWorks Test and other products, including its diagnostic kits for immunology disorders, vascular diseases, and bone and joint disorders.

AspirinWorks is a simple, non-invasive lab test performed on a urine specimen, which helps doctors accurately determine aspirin effect in apparently healthy individuals by measuring levels of 11-dehydro thromboxane B2 (11-dhTxB2). High levels of 11-dhTxB2, a metabolite of thromboxane — the target of aspirin therapy — heighten the risk of cardiovascular events, including stroke, myocardial infarction and cardiac death.

Millions of Americans take a daily aspirin to prevent heart attack or stroke but don’t know if the aspirin is having the desired effect. The goal of aspirin therapy is to reduce levels of thromboxane in the blood, decreasing platelet stickiness and therefore reducing the chance of forming a blood clot.

Unlike other functional platelet tests that require freshly drawn blood that must be evaluated in five hours, the AspirinWorks Test is performed on a random urine sample that can be obtained in any doctor’s office. Physicians and laboratories interested in ordering the test can call 1-800-729-5661 x180, or email info@aspirinworks.com. More information is also available at www.aspirinworks.com.

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, including the world’s only non-blood-based test for aspirin effect. 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 in product submissions to the FDA and other worldwide regulatory authorities. Additionally Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com (Corporate website) and www.corgenix.net (Contract Services website).

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.

 

Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP and CFO

Phone: 303-453-8903

Email: wcritchfield@corgenix.com

Media Contact:

Armada Medical Marketing

Dan Snyders, Vice President and Public Relations Supervisor
Phone: 303-623-1190 x230

Email: dan@armadamedical.com

Atherotech Diagnostics Lab adds Corgenix AspirinWorks® Test for Aspirin Effect

AspirinWorks® Test measures levels of inflammatory chemical thromboxane, which can interfere with heart-protective effect of aspirin therapy

DENVER — April 2, 2013Corgenix Medical Corporation (OTC BB: CONX), a worldwide developer and marketer of diagnostic test kits, has announced that Atherotech Diagnostics Lab will carry its AspirinWorks® Test for determining aspirin effect.

Under terms of the agreement, Corgenix AspirinWorks product will be used to assess aspirin effect as part of Atherotech Diagnostic Lab’s cardiometabolic testing products. AspirinWorks is the only U.S. FDA-cleared test that measures the urinary biomarker 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect.

“Atherotech is one of the nation’s most recognized and respected labs for comprehensive cardiometabolic testing and cardiovascular risk assessment,” said Douglass Simpson, Corgenix’ President and Chief Executive Officer. “Atherotech’s access to the U.S. primary care market further strengthens the AspirinWorks product, a test that has proven its clinical utility by measuring aspirin effect, thereby enabling physicians to identify an additional influence on aspirin’s ability to aid in reducing heart attack and stroke risk.”

The AspirinWorks Test identifies those individuals who have elevated thromboxane levels despite taking a daily aspirin dose, with studies showing up to 25 percent of individuals not seeing the expected beneficial effects of aspirin. The thromboxane metabolite 11dhTxB2 identified by AspirinWorks has been clinically validated through extensive research and numerous well-designed and well-powered clinical trials. The AspirinWorks 11dhTxB2 Test is FDA-cleared and used by thousands of physicians to test and guide treatment for hundreds of thousands of patients each year worldwide.

Atherotech provides a full complement of more than 60 routine and specialty diagnostic tests, including its patented VAP® Lipid Panel, to help physicians establish the most effective course of treatment from a single source.

About the AspirinWorks Test

Launched in the U.S. in June 2007 following FDA 510(k) clearance, the AspirinWorks Test is available nationwide through major medical laboratories. Unlike functional platelet tests, which require freshly drawn blood that must be evaluated within at least four hours, the AspirinWorks Test is performed on a random urine sample that can be obtained in any doctor’s office or patient service center, making the test convenient for both physician and patient. More information is also available at www.aspirinworks.com.

 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, including the world’s only non-blood-based test for aspirin effect. 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 in product submissions to the FDA and other worldwide regulatory authorities. Additionally Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com.

 

Company Contact:

Corgenix Medical Corp.
William Critchfield, Senior VP Operations and Finance and CFO
Phone (303) 453-8903
Email: wcritchfield@corgenix.com

Media Contact:

Armada Medical Marketing
Dan Snyders, Vice President,
Public Relations Supervisor
Phone: 303-623-1190 x 230
Email: dan@armadamedical.com

Atherotech Diagnostics Lab Expands Heart Disease Risk Assessment with AspirinWorks® Test

Test measures protective effect of aspirin therapy to better assess heart attack and stroke risk

BIRMINGHAM, Ala. – March 27, 2013 – Atherotech Diagnostics Lab, a leading clinical reference laboratory specializing in cardiometabolic testing and disease management solutions, recently launched the AspirinWorks® Test to complement its menu of cardiovascular disease risk assessment tests. Read More… Click Here

New Study Highlights Importance of Testing for Aspirin Effect with FDA-Cleared AspirinWorks Test

Study mistakenly focuses only on rare genetic condition of aspirin resistance, ignores most common causes of aspirin non-response

DENVER – December 6, 2012 – >By failing to address the most common causes of aspirin ineffectiveness, a small clinical study recently published online in the journal highlights the importance of clinically validated, FDA-cleared testing for aspirin effect with the AspirinWorks Test to help prevent heart attack and stroke.

In the Grosser, et al. study, University of Pennsylvania researchers looking at 400 healthy volunteers and the impact of enteric coated versus uncoated aspirin, narrowly focused on a rare, genetic resistance to the effect of taking aspirin and ignored the far more common causes limiting the effectiveness of aspirin.

Millions of Americans take a daily aspirin to reduce or prevent cardiovascular events. Aspirin works on blood platelets to decrease levels of thromboxane, the chemical in the body that makes platelets sticky. Lower thromboxane levels and decreased platelet stickiness means less chance of developing a blood clot and therefore, less chance of a heart attack or stroke. The AspirinWorks Test from Corgenix Medical Corp (OTC BB: CONX), which was not included in the study, is not intended to measure or diagnose what the study refers to as “genetic aspirin resistance,” and is in fact the only U.S. FDA-cleared test that measures the urinary biomarker 11-dehydro thromboxane B2 (11dTxB2) to determine aspirin effect.

“The study’s severe limitations, including the fact that it had absolutely nothing to do with our company’s AspirinWorks Test for aspirin effect, actually highlights the importance of screening patients who are taking aspirin,” said Corgenix President and CEO Douglass Simpson. “Doctors test patients because despite taking aspirin, their levels of the inflammatory chemical thromboxane could still be dangerously high, not just because they might have some rare genetic disorder.”

Despite the confusing reports about the Grosser et al trial, Simpson said the bottom line is that people taking a daily aspirin with continued high levels of thromboxane are at a clinically proven increased risk of heart attack or stroke compared to patients without elevated levels.

“While we strongly believe ignoring non-genetic causes of aspirin ineffectiveness is misleading, this study gives us the opportunity to further educate the medical community and the public they serve about the critical importance of testing for aspirin effect and understanding how it impacts risk,” continued Simpson.

Simpson emphasized that while so-called “genetic aspirin resistance” as defined in the study is rare, failure of patients to respond to the intended beneficial effect of aspirin is absolutely not rare. There are many roads that lead to aspirin effect or the lack thereof, putting patients at increased risk of heart attack and stroke. Reasons for the inability of aspirin to do its job include:

  • Diseases and other inflammatory processes that produce chemicals (thromboxane) that can reduce aspirin’s beneficial effect
  • Other medications that interfere with the intended anti-clotting effect of aspirin
  • Unusually high levels of stress
  • Genetically poor responders to aspirin therapy

The AspirinWorks Test identifies those individuals who have elevated thromboxane levels despite taking a daily aspirin dose, with studies showing up to 25 percent of individuals not seeing the expected beneficial effects of aspirin. Corgenix stated that their test has been clinically validated through extensive research and numerous well-designed and well-powered clinical trials. The AspirinWorks/11dhTxB2 Test is FDA-cleared and used by thousands of physicians to test and guide treatment for hundreds of thousands of patients each year worldwide.

“Our test tells physicians whether or not the aspirin their patients are taking is providing the adequate level of protection they expect,” said Simpson. “It remains the only product clinically validated to do so.”

About the AspirinWorks Test

Launched in the U.S. in June 2007 following FDA 510(k) clearance, the AspirinWorks Test is available nationwide through major medical laboratories. Unlike functional platelet tests, which require freshly drawn blood that must be evaluated within at least four hours, the AspirinWorks Test is performed on a random urine sample that can be obtained in any doctor’s office or patient service center, making the test convenient for both physician and patient. More information is also available at www.aspirinworks.com.

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, including the world’s only non-blood-based test for aspirin effect. 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 in product submissions to the FDA and other worldwide regulatory authorities. Additionally Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. 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. Such statements, which are inherently uncertain, are based on management’s current expectations and are subject to various factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such 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 reports filed with the Securities and Exchange Commission, and in the Company’s subsequent 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 or intend to publicly update or revise any forward-looking statements.

Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP Operations and Finance and CFO
Phone (303) 453-8903
wcritchfield@corgenix.com

Media Contact:

Armada Medical Marketing
Dan Snyders, Vice President,
Public Relations Supervisor
Phone: 303-623-1190 x 230
Email: dan@armadamedical.com

 

 

Corgenix Receives Regulatory Approval For Sale of Aspirinworks In China

DENVER – November 12, 2012 – Corgenix Medical Corporation (OTC BB: CONX.OB), a worldwide developer and marketer of diagnostic test kits, announced today that the Company’s AspirinWorksÒ ELISA product has received notification of regulatory approval from the State Food and Drug Administration (SFDA) of the Peoples Republic of China. The approval enables Corgenix to begin commercialization of the AspirinWorks diagnostic test kit in China, one of the world’s largest and fastest growing medical markets.

“Securing SFDA approval in China for diagnostic products is an extensive process, and in some ways more rigorous than securing clearance in the U.S.,” said Douglass Simpson, President and CEO of Corgenix. “As part of Corgenix’ corporate strategy to expand our global presence with our proprietary products and technologies, stablishing this presence in China is a major accomplishment, providing us ready access to a very large and growing market.”

In conjunction with its international distribution partner, The ELITech Group, Corgenix will begin selling the AspirinWorks product through Beijing Ningjiang Technology And Trade Co., Ltd, a prominent Beijing-based medical device distribution company. Corgenix Medical and Beijing Ningjiang are considering ways to further expand the relationship to include other diagnostic products and opportunities, and will be collaborating in clinical studies in major medical institutions in China.

“We expect that this agreement will boost our revenues by an additional three to
five percent this fiscal year,” continued Simpson. “That would be an outstanding accomplishment for first-year product sales goals, and we foresee potentially much greater levels over the next few years. There is tremendous growth potential in China, and Corgenix is prepared to serve the upcoming explosive demand for this testing, seizing any chance to become a key player in this promising market.”

AspirinWorks is the only U.S. FDA-cleared test that measures the urinary biomarker 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals post ingestion. 11dhTxB2 is a metabolite of thromboxane A2 (TxA2), the target of aspirin therapy. The test targets a potential global market exceeding 200 million individuals.

Unlike functional platelet tests, which require freshly drawn blood that must be evaluated within at least four hours, the AspirinWorks Test is performed on a random urine sample that can be obtained in any doctor’s office or clinic.

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, including the world’s only non-blood-based test for aspirin effect. 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 in product submissions to the FDA and other worldwide regulatory authorities. Additionally Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com.

 

Company Contact:

Corgenix Medical Corp.

William Critchfield, Senior VP Operations and Finance and CFO
Phone (303) 453-8903
wcritchfield@corgenix.com

Media Contact:

Armada Medical Marketing
Dan Snyders, Vice President,
Public Relations Supervisor
Phone: 303-623-1190 x 230
Email: dan@armadamedical.com