WINNIPEG, MANITOBA -- (Marketwired) -- 08/19/13 -- Editors note: There is one photo associated with this press release.
Miraculins Inc. (TSX VENTURE: MOM), ("Miraculins" or the "Company") a medical diagnostic company focused on acquiring, developing and commercializing diagnostic and risk assessment technologies for unmet clinical needs, is pleased to announce five new SCOUT DS® publications in peer-reviewed journals since April 2013. These studies include research demonstrating the superiority of the SCOUT DS® system when compared to random capillary glucose in an at-risk population, published in Diabetes Research and Clinical Practice in April 2013.
"The recent publication of a number of SCOUT DS® studies in well-respected, peer-reviewed journals, highlights the increasing scientific evidence in support of this product, the world's first non-invasive diabetes screening system," said Christopher J. Moreau, President and Chief Executive Officer of Miraculins Inc. "The SCOUT DS® is designed to provide a highly sensitive and convenient method for screening of pre-diabetes and type 2 diabetes based on the presence of diabetes-related biomarkers found in skin and we are pleased to see the supporting scientific evidence continue to build."
Recent SCOUT DS® publications are as follows:
1. Tentolouis N. et al. Screening for HbA1c-defined prediabetes and diabetes in an at-risk Greek population: Performance comparison of random capillary glucose, the ADA diabetes risk test and skin fluorescence spectroscopy. Diabetes Research and Clinical Practice 2013: 100(1): 39-45.
2. Cleary PA. et al. Clinical and Technical Factors Associated with Skin Intrinsic Fluorescence in Subjects with Type 1 Diabetes from the DCCT/EDIC Study. Diabetes Technology and Therapeutics 2013:15(6): 466-474.
3. Orchard TJ. et al. The Association of Skin-Intrinsic Fluorescence With Type 1 Diabetes Complications in the DCCT/EDIC Study. (Published online ahead of print June 28, 2013 Diabetes Care. Doi: 10.2337/dc12-2661.
4. Olson BP. et al. Noninvasive Skin Fluorescence Spectroscopy Is Comparable to Hemoglobin A1c and Fasting Plasma Glucose for Detection of Abnormal Glucose Tolerance. Journal of Diabetes Science and Technology 2013: 7(4): 990-1000.
5. Shah S. et al. Advanced glycation endproducts in children with diabetes. (Published online ahead of print August 5, 2013) Journal of Pediatrics. Doi: 10.1016/jpeds.2013.06.044.
In addition to these current publications, the clinical and scientific evidence underlying the SCOUT DS® has been developed in a number of clinical studies, across more than 30 clinical sites and over 3,000 patients.
Key clinical evidence for SCOUT DS® includes:
1. ENGINE trial, a prospective, multi-centre study which was conducted in 2010 on more than 500 patients at 12 clinical sites in the United States. The purpose of the ENGINE trial was a real-world comparison of SCOUT DS® to fasting plasma glucose (FPG) and HbA1c (glycated haemoglobin) for diabetes screening, and using a 2-hour oral glucose tolerance test (OGTT) as the reference standard. FPG and HbA1c are common laboratory based diabetes tests. The study concluded that SCOUT DS® detection of abnormal glucose tolerance was equivalent to FPG and HbA1c at false positive rates that are appropriate for screening, and furthermore the sensitivity of SCOUT DS® was higher than that of FPG and HbA1c at their common diabetes screening thresholds.
2. POSSE trial, a 2012 comparison of SCOUT DS® against random capillary glucose (RCG) in a workplace screening model of more than 650 individuals in a four day period. The trial was conducted in collaboration with Blue Cross/Blue Shield of Louisiana using HbA1c as the reference standard. The study concluded that SCOUT DS® was more accurate than RCG in this setting.
3. NSEEDS trial, a 2010/2011, multi-centre comparison of SCOUT DS® against FPG and Hba1c with 2-hour OGTT as the reference standard. In addition to demonstrating equivalence or superiority to existing methods, the study demonstrated reproducibility of the SCOUT DS® and showed that the coefficient of variation (CV) of the SCOUT DS® was equivalent to FPG.
4. GREECE trial, a 2011/2012, comparison of SCOUT DS® against random capillary glucose (RCG) and the American Diabetes Association diabetes risk test (ADADRT) with a 2-hour OGTT as the reference standard. The study demonstrated that the SCOUT DS® was superior to RCG and ADADRT for detection of diabetes and pre-diabetes.
5. TCOYD trial, a 2010/2011, assessment of SCOUT DS® as an accurate tool for identifying individuals with previously diagnosed type 2 diabetes. The study demonstrated the SCOUT DS® ability to correctly identify 93.7% of previously identified diabetic individuals.
About the SCOUT DS®
The SCOUT DS® system is the first non-invasive diabetes screening system designed to provide a highly sensitive and convenient method for screening for pre-diabetes and type 2 diabetes based on the presence of diabetes-related biomarkers found in skin. Unlike current screening methods, a SCOUT DS® test requires no blood draw, no fasting, and no waiting for a lab result. The product has been used and validated in thousands of patients around the world. The SCOUT DS® has received clearance from Health Canada for commercial distribution, has been granted a CE Mark in the European Union, and is also cleared for sale in Mexico. For more information visit www.miraculins.com.
About Miraculins Inc.
Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive technologies 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. 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® and SCOUT DS® are registered trademarks of Miraculins Inc. All Rights Reserved. 2013.
To view the image associated with this press release, please visit the following link: http://www.marketwire.com/library/20130819-892998_IMAGE_800.jpg
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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