Miraculins Gets Good News From FDA
Miraculins Inc. (TSXV: MOM) announced encouraging feedback from the United States Food and Drug Administration (FDA) as part of the de novo pre-submission process for the Scout DSTM, its proprietary diabetes screening device that detects biomarkers present in the skin of pre-diabetic and Type 2 diabetic patients.
FDA’s de novo process is generally considered to be appropriate for ‘novel’ medical devices for which there are no legally marketed predicate devices, and whose risk profiles do not warrant the regulatory pathway known as a premarket approval (PMA), which is required of products considered to have the highest risk to public safety (Class III).
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Miraculins must still complete and file their formal de novo marketing application and the FDA will then have 120 days to issue a classification which will ultimately affect the Scout’s DSTM market range and thereby its ability to inform 86 million Americans to visit their doctors and rethink their lifestyle and dietary choices.
Further Miraculins reported on the usefulness of the Scout as a means to gain in-depth consumer information for marketing purpose based on results reported in the Company’s press release on April 28th about the Scout DS® Diabetes Screening Kiosk pilot ‘The Pilot’ which was conducted in Southern Ontario in partnership with Lovell Drugs Ltd. and Pear Healthcare Solutions Inc. The Pilot demonstrated its usefulness by identifying 145 of over 350 individuals as at risk for pre-diabetes or Type 2 diabetes in just 16 days. All pharmacy customers who were identified as being at risk during the Pilot were recommended to follow-up with their physician for confirmatory blood testing.
Furthermore, pilot participants willingly, and seemingly cheerfully, submitted to a touch-screen survey while seated for their complimentary and non-invasive Scout DS® diabetes test, which resulted in the acquisition of valuable and traditionally difficult to procure consumer information.
More particularly, convincing customers to complete marketing surveys is notoriously difficult to achieve. Thus the willingness of pharmacy pilot customers to complete the survey while being tested demonstrates that a diabetes screening and customer surveying kiosk could be integrated anywhere. By anywhere, Paul Moreau, Vice President of Sales and Marketing for Miraculins means that the use of the Scout DS® diabetes testing device and process could realistically expand to retail store operations with large customer bases, as well as into shopping malls, airports and a variety of other public settings.
“Retailers, organizations and marquee brands in North America and abroad highly value actionable consumer information, which in practice is very hard to get. We believe they could use our kiosk to procure that data and deliver a brand message, while providing an important, complimentary healthcare screen to their customers for what is now being described as the fastest growing disease in history.”
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Dr. Luc C. Duchesne is a Speaker and Author with a PhD in Biochemistry. With three decades of scientific and business experience, he has published ... <Read more about Dr. Luc Duchesne>