Miraculins Inc. Announces Plans to Launch PREVU in Q4 2011
Published: Jan 11, 2011
WINNIPEG, MANITOBA--(Marketwire - January 11, 2011) - Miraculins Inc. (TSX VENTURE: MOM), a medical diagnostic company focused on developing and commercializing risk assessment and diagnostic tests for unmet clinical needs, has announced plans to make its PREVU(i) technology available for commercial sale in the fourth quarter of 2011. PREVU assesses the additional risk a person has for coronary artery disease (CAD) by measuring their level of skin cholesterol. High skin cholesterol readings have been shown in scientific studies to be a reliable predictor of higher cholesterol accumulation in the arteries, and accordingly, the risk of coronary artery disease.
PREVU has been previously cleared for sale as part of CAD risk assessment in Canada and CE marked for sale in Europe. The test has also been previously cleared for sale by the FDA in the United States as part of risk assessment for CAD in persons suspected of having significant CAD and/or persons with a history of myocardial infarction.
Since closing the acquisition of the PREVU technology in September 2010, Miraculins management has been focused on preparing all aspects of the product for market launch. Critical steps to achieve this significant milestone are underway and include:
-- reestablishing key manufacturing partnerships for both of the main components of the PREVU test, the reagent testing kits and the handheld reader (spectrophotometer); -- coordinating the establishment of an ISO 13485 certified quality system, enabling Miraculins to align its management system with regulatory requirements in order to become a medical device manufacturer of record; -- preparing for regulatory notifications required for medical device product marketing in Canada, the United States and Europe; -- refreshing the PREVU brand across all marketing and promotional platforms (including print and web), to most effectively communicate the full value proposition of the technology; -- evaluating sales channels to more expansively reach the end consumer, including retail chain pharmacies, employee health screening services, executive health centres, fitness and weight loss facilities, the life insurance industry, alternative healthcare, as well as primary care physicians and medical clinics; and -- conducting partnership discussions with multiple parties in Canada, the United States and Europe with the goal of activating targeted sales channels; and negotiating with interested parties for the licensing rights to PREVU in foreign markets.About PREVU
PREVU is a risk evaluation technology that assesses the additional risk a person may have for CAD by non-invasively testing their skin cholesterol level.
Skin contains 11% of the body's cholesterol deposits and ages in parallel with vascular connective tissue. As blood vessel walls accumulate cholesterol, so do the skin tissues. A high skin cholesterol level is therefore a trusted predictor of higher cholesterol accumulation in the arteries and, accordingly, the risk of heart disease. PREVU is supported and validated by numerous peer reviewed scientific and clinical studies, and has been correlated to coronary artery disease (CAD) as measured by angiography and carotid intima media thickness (CIMT), as measured by ultrasound testing.
Through the simple and painless application of reagents to the palm of a person's hand - which selectively bind to cholesterol in the skin and produce a colour change - and the subsequent reading of the precise color by a handheld reader (spectrophotometer), a person's additional risk for coronary artery disease (CAD) is established. The testing requires no fasting and is conducted without needles or blood draw. As such it is customer friendly, convenient and inexpensive with the results generally produced in under five minutes.
Coronary artery disease is a leading cause of death worldwide and occurs when fat and cholesterol accumulate in the coronary arteries over a period of years, forming a plaque that narrows the arteries and reduces blood flow to the heart. Undetected or untreated, this build-up can block the artery and cause a heart attack. A heart attack, also known as a myocardial infarction (MI), causes a part of the heart muscle to die, which weakens the heart's ability to pump blood. Worldwide, about 7.2 million people die from heart attacks each year.
Since skin cholesterol is a measurement of actual cholesterol accumulation and deposits in tissue, it provides different information from that measured using serum cholesterol testing. PREVU has been designed to provide additive information to this and other risk factors including Framingham risk testing, to more comprehensively determine a person's refined risk of having a heart attack.
About Miraculins Inc.
Miraculins is a medical diagnostic development company focused on non-invasive tests for unmet clinical needs. Miraculins is bridging the gap between commercially available risk assessment and diagnostic tests and research conducted at leading research institutions around the world. The Company recently acquired the PREVU technology, a non-invasive, inexpensive and painless tool for CAD risk assessment that generates results in minutes. PREVU has been previously cleared for sale in Canada and CE marked for sale in Europe. The product has also been previously cleared for sale by the FDA in the United States as part of risk assessment for coronary artery disease (CAD) in persons suspected of having significant CAD and/or persons with a history of heart attack. Additionally, the Company's preeclampsia program, a suite of biomarkers to aid in the early detection of this devastating disease of pregnancy, 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 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.
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Christopher J. Moreau
President and CEO