Miraculins first in class for seeking FDA approval for a diabetes screening device
Miraculins Inc. (TSXV: MOM) is expanding its market reach by seeking class II medical device approval by the FDA for its flagship commercial product, the Scout DSTM, a diabetes screening device that detects biomarkers present in the skin of pre-diabetic and Type 2 diabetic patients. The devise is non-invasive and painless to use: it performs its tests without needles, finger pricking, blood draw or the need to fast, or even waiting at the lab for a grumpy technician to stick a needle up your arm.
The Company reports that is has identified a pathway toward the FDA approval based on interactions with the FDA in 2014, including a meeting between a Miraculins delegation and FDA representatives in Washington, D.C. In its press release of February 18, 2015 the Company stated that there is no predicate device for the Scout® which would speed up FDA approval. This is good news to investors looking to invest in potentially disruptive technologies, as the US market for diabetes screening is significant and ever expanding.
A predicate devise is a similar device with a similar function and similar modes of action. That the Scout® has no predicate devise means the Scout® is a standalone product that may be disruptive in the marketplace. Think of the Blackberry when it hit the market. It stood alone until imitators came in.
I am not sure how long it will take to get FDA approval but past clinical studies on the device should speed up the process as the machine is based on algorithms derived from 16,000 tests in research trials and 4,000 tests in clinical settings. I would hope these results would speed up approval.
The Scout® identifies skin markers that fluoresce under certain wavelengths. The device scans a patient’s skin and then proprietary algorithms calculate a single diabetes score.
To explain how the device works we have to travel back to those awkward teenage dances in community centres. Remember the ubiquitous black lights? Remember how lint tended to glow in the dark and how some pieces of underclothing tended to change colors, sending the boys into breathless hormonal tizzies? The former phenomenon is called fluorescence whereas the latter is called adolescence. In practice every substance on earth has a unique fluorescence pattern (it emits lights of different colors when subjected to different wavelengths).
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Think of a CSI episode when the high-heeled investigator turn off the lights and shine a black light to study blood splatter which lights up? This is also called fluorescence.
Miraculins is a Canadian biotechnology company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs to bridge the gap between promising diagnostic biomarker opportunities and the marketplace. It’s lead technology program aims at development and commercialization of non-invasive screening tests to assist in the detection of diabetes and coronary artery disease.
Miraculins reached revenue stage last September when it announced a deal that could eventually lead to as much as $90 million in revenue for Miraculins, Catalyn Medical Technologies Limited, a privately-owned and Hong Kong based medical device import company, has agreed to be the exclusive distributor in China of the Scout DS.
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>