Miraculins PreVu Test CE Marked and Registered in the European Union
Company Readies for European Sales and Marketing
(firmenpresse) - WINNIPEG, MANITOBA -- (Marketwire) -- 01/30/12 -- Miraculins Inc. (TSX VENTURE: MOM), a medical diagnostic company focused on developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces that its PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test has now been CE Marked and is officially registered within the European Union. CE Marking allows the PreVu POC test to be marketed in the European Union for coronary artery disease risk assessment screening for use within the general population.
"We believe that PreVu can play a prominent role in the battle against one of the world's leading causes of death, by helping to better detect those who possess hidden, high levels of risk of coronary artery disease," said Christopher J. Moreau, President and CEO of Miraculins. "Completion of the CE Marking process and registration with European Competent Authorities is another significant step towards our goal of making this important risk assessment tool available worldwide."
CE marking confirms that the PreVu Non-Invasive Skin Cholesterol POC Test complies with the Essential Requirements of the European In Vitro Diagnostic Directive 98/79/EC, part of which includes the requirement to possess a certified Quality Management System. Miraculins was issued its formal ISO 13485 Certificate of Registration by The BSI Group Inc. on January 13, 2012.
"The PreVu POC test has met regulatory registration requirements for sale in the European Union allowing us to provide coronary artery disease risk assessment screening for the general population, representing a major market opportunity for Miraculins," added Moreau.
About The PreVu Non-Invasive Skin Cholesterol Test
PreVu is a non-invasive risk assessment technology that evaluates the additional risk a person may have for coronary artery disease (CAD) by conveniently and painlessly testing their skin cholesterol level. High levels of skin cholesterol have been shown to be correlated to CAD as measured by stress test, angiography, coronary calcium, and carotid intima-media thickness, inflammatory markers of vascular disease, previous heart attack incidents and Framingham risk score.
About Miraculins Inc.
Miraculins is a medical diagnostic development company focused on acquiring and advancing non-invasive tests for unmet clinical needs. The Company's PreVu test is a revolutionary new coronary artery disease (CAD) risk assessment technology that measures cholesterol levels in a patient's skin non-invasively, painlessly and without the need for fasting. PreVu has previously been successfully test marketed in North America on a limited basis. Miraculins additional programs include a research use only ELISA kit for the detection of PSP94; and a suite of biomarkers to aid in the early detection of the devastating disease of pregnancy known as preeclampsia. The Company's preeclampsia program is being advanced in partnership with Alere, Inc. (NYSE: ALR) (formerly known as Inverness Medical Innovations), one of the world's largest diagnostic companies. For more information on Miraculins please visit .
Caution Regarding Forward-Looking Information
Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, our anticipated future operating results, and can, in some cases, be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
These statements reflect management's current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: Miraculins' early stage of development, lack of product revenues and history of operating losses, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition, potential product liability, additional financing requirements and access to capital, unproven markets, supply of raw materials, income tax matters, management of growth, partnerships for development and commercialization of technology, effects of insurers' willingness to pay for products, system failures, dependence on key personnel, foreign currency risk, risks related to regulatory matters and risks related to intellectual property and other risks detailed from time to time in Miraculins' filings with Canadian securities regulatory authorities, as well as Miraculins' ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release. Miraculins cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on Miraculins' forward-looking statements to make decisions with respect to Miraculins investors and others should carefully consider the foregoing factors and other uncertainties and potential events.
These risks and uncertainties should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, Miraculins cannot provide assurance that actual results will be consistent with these forward-looking statements. Miraculins undertakes no obligation to update or revise any forward-looking statement.
® PreVu is a registered trademark of Miraculins Inc. All Rights Reserved. 2011.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contacts:
Miraculins Inc.
Christopher J. Moreau
President and CEO
204-477-7599
204-453-1546 (FAX)
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Datum: 30.01.2012 - 14:10 Uhr
Sprache: Deutsch
News-ID 108915
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WINNIPEG, MANITOBA
Kategorie:
Biotech
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