|By Marketwired .||
|September 5, 2013 06:30 AM EDT||
WINNIPEG, MANITOBA -- (Marketwired) -- 09/05/13 -- Miraculins Inc. (TSX VENTURE:MOM), ("Miraculins" or the "Company"), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today the 20 store locations where H-E-B, the #1 food retailer in South and Central Texas and the State's largest private company, will be conducting a pilot launch of the Company's PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test this fall. This is the first such launch of the product into the United States.
The H-E-B stores offering the PreVu® POC Test to qualifying customers approved by an on-site Licensed Practitioner will be located in San Antonio, Austin, Kerrville, Edinburg, Corpus Christi, Pflugerville, San Marcos, Harlingen, Georgetown, Houston and Friendswood.
The PreVu® POC Test will be offered as part of H-E-B's popular Second Saturday Screening program, where certified screeners from the H-E-B Pharmacy team offer cardiovascular risk assessment tests to customers on the second Saturday of the month from 9 am - 2 pm. The PreVu® POC Test will be selectively offered as part of this clinical community outreach, along with other risk assessment testing, including blood serum cholesterol, during the months of October, November and December.
"We are very pleased with the location of the stores for the upcoming pilot," said Paul Moreau, Vice President, Sales and Marketing for Miraculins Inc. "They provide us with a strong diversity of cities, towns and communities within the southern/central portion of the state, and allow us access to a mosaic population base that runs from Austin all the way down to the Texas/Mexico border."
Pursuant to the agreement, on the completion of the Phase One launch H-E-B will have the option to expand PreVu® POC testing to additional H-E-B locations commencing in 2014.
About The PreVu® Non-Invasive Skin Cholesterol (POC) Test
The PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test is a rapid, two-step, in vitro diagnostic test for the detection of cholesterol present in skin tissue, elevated levels of which have been shown in clinical studies to be associated with an increased risk of coronary artery disease. Skin contains approximately 11% by weight of all body cholesterol and has been cited in clinical studies as "mirroring" vascular changes associated with age and atherosclerosis.(1) More recent studies showing a relationship between elevated skin cholesterol levels and treadmill stress test outcome(2), and skin cholesterol correlated with angiographically proven CAD(3), have also been reported. The PreVu® POC Test is completely painless, non-invasive, involves no blood draw or needles, and requires no overnight fasting. Skin cholesterol is different than blood cholesterol and it is measured differently. It is not a substitute for blood cholesterol testing, but provides an important new perspective on cholesterol load in the body. The PreVu® POC Test can be used in conjunction with clinical evaluation and other lipoprotein tests as part of risk assessment for coronary artery disease in selected patients and will aid physicians in focusing diagnostic and patient management options.
(1) Lopukhin YuM. The skin and atherosclerosis (a three-drop test). Physiochemical Aspects of Medicine Reviews. 1992; 3:1-124. (2) Zawydiwski R, Sprecher DL, Evelegh MJ, et al. Cholesterol 1,2,3(TM): A novel test for the determination of skin cholesterol levels. Clinical Chemistry 2001; 47:1302-1304. (3) Sprecher DL, et al. Skin Tissue Cholesterol (Skin Tc) is related to angiographically-defined cardiovascular disease. Atherosclerosis 2003; 171:255-258.
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® POC Test technology is a rapid, two-step, in vitro diagnostic test for the detection of cholesterol present in skin tissue, which is non-invasive, painless and requires no fasting. The Company's 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. Miraculins is also advancing a suite of biomarkers to aid in the early detection of the devastating disease of pregnancy known as preeclampsia. The lead marker in the Company's preeclampsia program is partnered with Alere Inc., one of the world's largest diagnostic companies.
FDA Indication for Use: PreVu® Non-Invasive Skin Cholesterol POC Test
Skin cholesterol as measured by the PreVu Non-Invasive Skin Cholesterol POC Test can be used as part of risk assessment for coronary heart disease in persons with a history of myocardial infarction and/or persons suspected of having significant multi-vessel coronary artery disease (greater than 50% stenosis in greater than 1 vessel as diagnosed by coronary angiography) where further diagnostic evaluation is being considered. Test results, when considered in conjunction with clinical evaluation, blood cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.
Warnings: The safety and effectiveness of this device for use in screening the general population for coronary artery disease or for use as a substitute for blood cholesterol tests or as a substitute for other risk factors for coronary artery disease has not been established.
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.
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 include statements regarding the execution of definitive documentation and completion of the transaction. 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.