Miraculins Inc announces 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."

Source: Miraculins