WINNIPEG, MANITOBA--(Marketwire - Nov. 19, 2012) - 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 is pleased to provide the market with a summary overview of its key operating, marketing and distribution accomplishments for PreVu®, the Company's Non-Invasive Skin Cholesterol Test technology, for the 2012 fiscal year.
"Miraculins accomplished a significant number of meaningful milestones over the past year," said Christopher J. Moreau, President and CEO of Miraculins. "Our dedicated team has worked with diligence and a high standard of professionalism towards our goal of ensuring that PreVu becomes an internationally recognized and utilized early screening test for risk of coronary artery disease (CAD). We are pleased to provide the following summary of our accomplishments for 2012. We will be updating the market on our plans and strategy for 2013 shortly."
- Prepared for Commercialization and Met Regulatory Requirements
- Received formal ISO Certificate of Registration by The BSI Group Inc. designating Miraculins as a medical device manufacturer with a certified quality management system
- PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test CE Marked and officially registered within the European Union
- PreVu® Non-Invasive Skin Cholesterol POC Test cleared for sale by Health Canada
- Outlined and reiterated details of the FDA's clearance for its PreVu® Non-Invasive Skin Cholesterol POC Test, which was issued prior to Miraculins' acquisition of the PreVu technology and remains in effect in the U.S. marketplace
- Developed and launched an English language Canadian web site for its PreVu® Non-Invasive Skin Cholesterol POC Test at www.prevu.com
- Developed and launched a French language Canadian web site for its PreVu® Non-Invasive Skin Cholesterol Test at www.prevu.com
- Received Notice of Allowance from the United States Patent and Trademark Office for a patent that covers the use of spectrophotometric measurements for the non-invasive analysis of skin cholesterol (POC technology) and issued a patent by the State Intellectual Property Office of the People's Republic of China that covers use of a tape stripping device for skin sampling (LP technology)
- Established Distribution Partnerships and Developed Sales Channels
- Entered into an agreement with The Stevens Company Limited - the largest, privately-owned Canadian distributor of hospital, physician and nursing home supplies - that will see the PreVu® Non-Invasive Skin Cholesterol POC Test distributed to the Canadian medical market
- Entered into an agreement with Pear Healthcare Solutions Inc., a leading provider of in-pharmacy health screening and education services, that will see the PreVu® Non-Invasive Skin Cholesterol POC Test distributed to the Canadian retail pharmacy market segment
- Successfully completed the retail pharmacy launch of the PreVu® Non-Invasive Skin Cholesterol POC Test in 11 London Drugs locations in Western Canada, which generated a dynamic response from the public and media. The launch included the provision of store level promotion and advertising and the validation of a number of logistical processes, resulting in a number of patients tested with PreVu at an introductory price of $19.99
- Conducted an expansive education and awareness campaign to over 3,600 medical doctors in Vancouver/Lower Mainland as well as Winnipeg (pilot regions) in advance of the London Drugs launch
- Strengthened Financial Position
- Closed a private placement offering (the "Offering") with aggregate gross proceeds to the Company of $2,452,292
- Received $130,000 in grant funding from the Manitoba Commercialization Support for Business (CSB) Program to support commercialization of its PreVu® Non-Invasive Skin Cholesterol Test
- Retained Experienced Leaders/Advisors
- Renowned cardiologist Dr. G.B. John Mancini, MD, FRCPC, FACC appointed to the PreVu Medical Advisory Board and named Chair
- Preeminent Canadian Cardiologist, Scientist and University Professor, Dr. Milan Gupta, MD, FRCPC, FACC appointed to the PreVu Medical Advisory Board
- Distinguished U.S. Cardiologist Dr. Henry A. Solomon, MD, FACP, FACC appointed to the PreVu Medical Advisory Board as first U.S. based member
- Appointed renowned international fund manager Jim Mellon to the Miraculins Board of Directors
- Appointed broadcast media executive William (Bill) Roberts to the Miraculins Board of Directors
About the PreVu Non-Invasive Skin Cholesterol Test
The PreVu® 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. 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. 2012.
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