Non-invasive diabetes test provides “Miraculins” results through technology
June 12, 2015 — Tracy Weslosky, Editor-in-Chief and Publisher of InvestorIntel speaks to Christopher Moreau, President, CEO & Director for Miraculins Inc. (TSXV: MOM) about the Scout technology, a non-invasive diabetes test and their recent promising results as supported by the joint MIraculins and Amway Scout DS® study being accepted for the 23rd World Congress of Dermatology. In addition to this, a follow-up on the recent good news from the FDA and an update on the $90mm value deal with a Chinese pharmaceutical company, they discuss Miraculins shareholder value and health issues relating to diabetes.
Tracy Weslosky: Today I have the pleasure of speaking with Chris Moreau from Miraculin. Of course, you have the non-invasive diabetes testing — you got ‘the Scout’?
Christopher Moreau: Yes, we have the Scout.
Tracy Weslosky: What I would like to know, but what’s happening with the U.S. FDA?
Christopher Moreau: We had very good news that we had announced, based on our feedback from the U.S. FDA that we are going to continue down a pathway called the de novo path for a class 2 device in the U.S. and we hope to have some additional news soon for the market.
Tracy Weslosky: For those of us that may not understand the biotech industry as well as Chris does, can you tell us what this means for the timeline and why this is such exciting news?
Christopher Moreau: What it means is that typically in the U.S. to go for a class 2 designation you need to have a predicate device meaning there needs to be a comparable device on the market that you can point to. There is no predicate device for the Scout, but there’s an exception in the U.S. FDA called the de novo pathway where if you don’t have a predicate device you can rely on this pathway. It’s much easier than being a class 3. That’s much more expensive. It’s more time consuming and if we can continue for a de novo pathway for the U.S. FDA in the Scout, it’s very good news for shareholders.
Tracy Weslosky: This is very good news for shareholders, so can you tell us what this process timeline might be like, best-case scenario?
Christopher Moreau: Generally speaking, studies for a class 2 depends on the size of the study. There are some details we’re still working through with the FDA so I’m not going to be able to give you a specific timeline. We are hoping to begin more specific plans for a study in the fall. The size of the study and how long it will take we’ll be able to update the market at that time.
Tracy Weslosky: Of course, you just put out news about a study that you’ve done with Amway. Can you tell us more about this?
Christopher Moreau: Yes. Amway reached out to us and wanted to do a study. They have a device that’s very expensive that can scan a person’s skin and tell whether that skin’s been damaged either by excessive UV, damage below the surface. This is a device that they use that is very expensive. It’s not mobile. They had read about the Scout and….to access the rest of this interview, click here
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