WINNIPEG, MANITOBA -- (Marketwire) -- 02/12/13 -- Miraculins Inc. (TSX VENTURE: MOM), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today the start of a pilot study to measure skin cholesterol levels in patients beginning statin therapy. The pilot study, sponsored by Miraculins, is being conducted at the Winnipeg Clinic and will measure skin cholesterol levels using the second format of Miraculins' PreVu® Non-Invasive Skin Cholesterol Test technology - The PreVu Lab Processed (LP) Test. The study is designed to assess the degree of correlation between changes in skin cholesterol and serum cholesterol during statin treatment, and how statin treatment impacts skin cholesterol levels based on measurements taken at multiple time points over a six-month period.
Statins are a class of lipid lowering drugs that inhibit cholesterol biosynthesis in the liver. They have emerged as one of the best-selling medication classes and are the most widely prescribed lipid lowering medication in the world. In 2011, over 20 million Americans were taking some type of statin.
"This pilot study, in a small number of patients, is meant to establish a clearer signal for the behavior of skin cholesterol in response to therapy. Although a great deal of clinical evidence exists establishing the utility of measuring skin cholesterol as a risk factor for coronary artery disease, limited scientific data has been developed to understand the behavior of this novel biomarker over multiple time points, particularly in response to the administration of therapy such as statins," commented Dr. Michael J. Evelegh, Vice President, Product Development of Miraculins Inc. and co-author of numerous publications on skin cholesterol.
"Statins are one of the most frequently prescribed drugs and patients taking these medications must periodically provide blood samples for testing, which can be unpleasant and inconvenient. Additionally, statins are one of the most patient-neglected medications prescribed, with significant numbers of patients failing to maintain their medication regimens. Should skin cholesterol ultimately be shown to correlate with response to therapy, this non-invasive skin cholesterol test might prove in the future to be a more convenient drug therapy monitoring method," continued Dr. Evelegh.
"We are active in advancing our PreVu LP Test and supporting the scientific development and awareness of skin cholesterol as an emerging biomarker in the fight against coronary artery disease," said Christopher J. Moreau, President and CEO of Miraculins Inc. "This pilot study is consistent with our stated plans and goals for 2013, which include exploring additional test utilities. Based on a promising result the Company will be in a better position to consider alternatives for a larger study and for potential additional commercial opportunities that could result."
The PreVu LP Test, Miraculins' second testing format for skin cholesterol is being developed with Gamma-Dynacare Medical Laboratories, the Company's exclusive Canadian PreVu LP Testing partner. The PreVu LP Test non-invasively measures the amount of cholesterol that has been deposited in skin tissues by painlessly and rapidly collecting skin cells from the palm of the hand using a proprietary medical adhesive collection device, which is then sent to a central reference laboratory for processing and results reporting.
An earlier version of the PreVu LP Test has previously been cleared for use in Canada and CE Marked in the European Union. At present, the PreVu LP Test is not cleared for sale in any jurisdiction.
About the PreVu Non-Invasive Skin Cholesterol Test
The PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test is a non-invasive, risk assessment technology designed to measure Skin Cholesterol - an important new biomarker in assessing risk of coronary artery disease ("CAD"). The PreVu® POC Test is completely painless, non-invasive, involves no blood draw or needles, and requires no overnight fasting. This in vitro diagnostic test is conducted on the palm of the hand in less than 5 minutes with results being immediately available, facilitating point of care consultation and a next steps discussion. Skin Cholesterol is the cholesterol that has been deposited and diffused into tissue, as opposed to freely circulating in the bloodstream, and the skin contains approximately 11% of all the cholesterol found in the human body, by weight. Elevated Skin Cholesterol has been shown in clinical studies to be strongly associated with significant CAD as measured by treadmill stress testing and coronary angiography, as well as measured by testing for coronary calcium, carotid artery thickening, and carotid artery plaque. The PreVu POC Test does not diagnose the presence or absence of CAD, but helps to identify patients who may be at higher, hidden risk for CAD by measuring this new biomarker. For more information, visit www.prevu.com.
About Miraculins Inc.
Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive tests for unmet clinical needs. A significant number of promising diagnostic opportunities remain un-commercialized because of the sizable gap between the discovery stage, when research institutions are typically involved, and the commercialization stage, when the larger commercial enterprises become interested. Miraculins has direct experience in bridging this gap. The Company's PreVu® technology is a revolutionary new coronary artery disease risk assessment technology that measures cholesterol levels in a patient's skin non-invasively, painlessly and without the need for fasting. Miraculins is also advancing 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 partnered with Alere Inc., one of the world's largest diagnostic companies. For more information, visit www.miraculins.com.
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. 2013.
Neither the 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.
Christopher J. Moreau
President & CEO
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