"After 15 months of building an ISO 13485 Certified Quality Management System, establishing new manufacturing and supply chain management relationships, meeting additional regulatory requirements and addressing other business plan objectives we have now received the clearance necessary to begin selling PreVu across Canada," said Christopher J. Moreau, President and CEO of Miraculins Inc.
PreVu is a Canadian developed, non-invasive risk assessment technology designed to measure skin cholesterol - a valuable new biomarker for the risk of coronary artery disease. PreVu evaluates the additional risk a person may be under for coronary artery disease (CAD) by quickly and painlessly measuring skin cholesterol levels on the palm of the hand without using needles, drawing blood or requiring overnight fasting. The test is conducted in less than 5 minutes with results being immediately available.
Skin contains over 10 percent of the body's cholesterol and ages in parallel with vascular connective tissue. Elevated skin cholesterol has been shown in multiple studies to be a reliable predictor of higher cholesterol accumulation in the arteries, which can interact with other elements to form atherosclerotic plaque lesions. High levels of skin cholesterol have been shown in clinical trials to be associated with an elevated risk of CAD as measured by treadmill stress testing, coronary angiography, coronary calcium, and carotid artery thickening.
PreVu offers an important new clinical tool for risk stratification in the primary prevention of CAD. The test is practical for general screening as it is able to be conducted in a primary care setting and allows the patient to be better targeted for primary prevention.
"Today's announcement means we are now fully cleared to offer this groundbreaking risk assessment technology to all Canadians. The test has been developed to help better detect those at risk of CAD and who could most benefit from primary prevention measures to help guard against a first heart attack or related event," said Moreau.