Healthcare Industry News: Inverness Medical Innovations
News Release - May 10, 2010
Miraculins Signs Letter of Intent to License FDA Cleared PreVu Skin Cholesterol TestWINNIPEG, MANITOBA--(HSMN NewsFeed) - Miraculins Inc. (TSX-V:MOM ), a medical diagnostic company focused on developing and commercializing diagnostic tests for unmet clinical needs is pleased to announce that it has signed a letter of intent (LOI) with PreMD Inc. to license the exclusive worldwide rights to the PreVu Skin Cholesterol Test, a simple non-invasive diagnostic test for the quantification of skin tissue cholesterol (skin sterol). Developed as a cost effective method of assisting with the risk assessment of coronary artery disease (CAD), the product has received FDA clearance and has been successfully test marketed in the United States and Canada.
The LOI sets out the key financial terms of the proposed license including an upfront fee, ongoing royalties and a future buyout provision. As per the terms of the LOI, Miraculins has an exclusive period to conclude its due diligence process and to finalize definitive documentation. The execution of definitive documentation and the completion of the transaction is subject to all necessary contractual, regulatory and corporate approvals of each of Miraculins and PreMD and the completion of satisfactory due diligence by Miraculins.
As a relatively new risk factor for heart disease, skin cholesterol provides valuable additional information for CAD risk assessment. Skin contains over 11% of the body's cholesterol and ages in parallel with vascular connective tissue. As blood vessel walls accumulate cholesterol, so does skin tissue. A high skin cholesterol level is a reliable predictor of higher cholesterol accumulation in the arteries and, accordingly, risk of heart disease.
The test has been cleared in important jurisdictions such as Europe and Canada as a general part of CAD risk assessment. In the United States, the test has received clearance as an adjunct to current risk assessment procedures for patients considered at risk for CAD.
"The PreVu Skin Cholesterol test represents a tremendous business opportunity for Miraculins and we plan to aggressively target the growing worldwide coronary artery disease risk assessment market," stated Christopher J. Moreau, President and CEO of Miraculins. "As the first FDA cleared product in our pipeline, this test would represent another step towards Miraculins' goal of becoming a world class diagnostic company."
"We are excited about the possibility of seeing the PreVu test given new life through partnership with Miraculins," said Dr. Brent Norton, President of PreMD Inc. "Miraculins has a unique opportunity to quickly unlock the technology's value and bring this product to the broader marketplace where it can help patients."
Further updates will be provided upon the execution of definitive documentation. There is, however, no assurance that the parties will enter into definitive documentation or complete the transaction contemplated by the LOI. If the definitive documentation is not entered into by the parties, or the exclusivity period is not extended by the parties, on or before August 7, 2010, the LOI will expire. Bloom Burton & Co. is advising on the transaction.
The PREVU Skin Cholesterol Test non-invasively and painlessly measures skin tissue cholesterol, or skin cholesterol. As a new risk factor for heart disease, skin cholesterol provides valuable additional information to traditional CAD risk assessment. Skin contains over 11% of the body's cholesterol and ages in parallel with vascular connective tissue. As blood vessel walls accumulate cholesterol, so does skin tissue. A high skin cholesterol level is a reliable predictor of higher cholesterol accumulation in the arteries and, accordingly, risk of heart disease. For further information about PreVu visit www.prevu.com.
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 diagnostic tests and research conducted at leading research institutions around the world. The Company's lead program, a suite of biomarkers for preeclampsia, is partnered with Inverness Medical Innovations (NYSE:IMA ), one of the world's largest diagnostic companies.
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"), such as statements regarding the execution of definitive documentation and the closing 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: the satisfaction of all of the closing conditions of the transaction, 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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