Miraculins Scout DS® may qualify for faster US FDA de novo approval pathway
Every 10 seconds, three new cases of type 2 diabetes are diagnosed. Fortunately, exceptional technology has now been developed to help in the earlier detection of pre-diabetes—the staging ground for type 2—towards drastically reducing that number.
The World Health Organization predicts 300 million cases of diabetes globally by 2025—a tenfold increase since 1985. For most countries, the largest single item of diabetes expenditure is hospital admissions for the treatment of long-term complications, such as heart disease and stroke, kidney failure and foot problems. Many of those cases are potentially preventable given effective pre-diabetes screening, where a disease trend can be caught and dealt with early on.
In the US and western nations, the rapid growth of the disease is straining health care. Those numbers will only get worse. Without doubt, new tests and treatments are critical, particularly for early detection through convenient and accessible pre-screening.
“In the US, $116 billion of a total $174 billion of the cost of diabetes treatment is for direct medical costs such as care and treatment,” stated Christopher Moreau, President and CEO of Miraculins Inc. (TSX.V: MOM). “Our patented Scout DS® device is the world’s first non-invasive and highly sensitive test designed to screen for pre-diabetes related biomarkers in the skin. It does not require a blood draw, needles or fasting, and generates a result in as little as 80 seconds. We believe the benefits to the US and global medical systems—and most importantly patients—are strikingly apparent.”
The Scout DS® uses visible light to fluoresce and measure the optical signature of certain biomarkers in the skin, which we all naturally have, but are hyper-expressed and accumulate in far greater numbers when we are pre-diabetic as a result of long-term glycemic exposure and oxidative stress. Patients with elevated Scout DS® test results are then recommended to see their physicians for follow-up and definitive blood work.
While cleared as a clinical tool to aid in the diagnosis of both pre-diabetes and type 2 diabetes in several jurisdictions including Canada, Mexico and the EU, Miraculins expects to hear in mid-October regarding the FDA application process it can access for its narrower pre-diabetes screening utility in the US. Due to the fact that Miraculins has been positioning the Scout DS® exclusively as a pre-diabetes screening technology for the US and not as a type 2 diabetes diagnostic aid, the Company has been making the case to qualify for the FDA’s ‘de novo’ classification pathway for regulatory approval. That process is much faster, cost-effective and less time consuming than the standard ‘premarket approval process’ (PMA) for diagnostic technologies, which can take 3-5 years and involve lengthy, expansive and costly clinical trials.
The previous owner of the Scout DS® (Miraculins purchased the technology as a distressed asset) attempted to gain FDA approval through a PMA for the device for use as a diagnostic screener for Type 2 diabetes, and was unsuccessful.
The Miraculins strategy was to adjust the utility for the Scout DS® in the US and file pre-submission documentation with the FDA in 2014 and the first quarter of 2015 regarding the de novo classification of the Scout DS® device as a next step towards securing marketing clearance in the United States. The de novo process is generally considered to be appropriate for “novel” medical devices whose risk profiles do not warrant the Class III designation reserved for diagnostic products (PMA), which is a more expensive and time consuming approval process.
Smaller biotech companies like Miraculins are doing much of the most exciting work in disease-state screening detection today. While the key is obviously the technology, the point for investors is to find those opportunities that reach the largest markets, have the best efficacy, are easy to use and readily available at low cost.
Miraculins is also not just focusing on the US market and waiting for an FDA response. It has and continues to build the sales infrastructure and pipelines to ramp up if approval is granted, and continues to work in other market channels and jurisdictions as well. For example, Miraculins is also focused on workplace screenings in partnership with established wellness and health providers in Canada and the EU, and still has its deal in China to sell Scout DS® devices into the hospital system there on approval of the Chinese Food and Drug Administration in that country (CFDA).
Dr. Alain Sotto, Investigative Coroner for Ontario’s York Region, TTC Occupational Medical Consultant and Director of Medcan Wellness Clinic and now on MOM’s scientific advisory board, has used the Scout DS® device for a couple of years in several workplace environments.
He states, “The Scout DS® is an excellent device for biometric screening for diabetes. Due to the non-invasive nature of the test, acceptance was high, resulting in employees accessing further testing if necessary and employers saving on healthcare costs as a result of early indications.” Sotto continues, “More than 3 million (or 1 in 10) Canadians have diabetes, with 90% being type 2 and more than 6 million (20%) have pre-diabetes and metabolic syndrome and don’t even know it. Screening devices such as the Scout DS® are critical to alleviate both the rapidly rising costs associated with diabetes and patients’ suffering and death due to this terrible disease.”
Several Scout DS® diabetes screening clinics have also been conducted in the Retail Pharmacy/Grocery Chain segment in Canada, by both national and independent store owners. Data collected through surveys of participating pharmacy staff and patients has been positive.
Utilizing the Miraculins Scout DS® technology to screen for diabetes in these retail applications, is anticipated to be highly appealing to pharmacies and grocery stores, as patients who go on to be diagnosed for pre-diabetes or type 2 diabetes have a hard dollar value at the pharmacy counter and in the grocery aisles. Independent research has shown that type 2 diabetes patients can spend an average of $6,000 per year on costs for treating their disease and that upwards of $3,000 of this may be spent at the pharmacy. Those with pre-diabetes also represent a hard dollar spend as well on preventative products and services, including fresher food choices to support changes to diet and lifestyle as a way of slowing down or stopping their progression to a type 2 condition.
While unclear at this point exactly who will pay for what will be an inexpensive test, there is little doubt the business risk/reward favours payment by the pharmacy/clinic or employer, and potentially health care systems and/or insurance companies, to help ensure widespread participation by the public.
As the US approval process unfolds, Miraculins announced on August 14, 2014 that it signed a major sales and distribution agreement with Catalyn Medical Technologies of Hong Kong for up to $90 Million USD in Scout DS® devices and co-appointed Cachet Pharmaceutical Co., Ltd. (“Cachet”) as the exclusive distributor of the Scout DS® device in Mainland China for a term of 5 years from the procurement of regulatory approval in the territory (pending Chinese regulatory approval).
Moreau added, “We believe strongly in the Scout DS® technology and in its capacity to impact patients in need worldwide, and we believe in the corresponding potential of our company to build and achieve significant value for shareholders along the way.”
One gets the sense that CEO Chris Moreau and his team cares as much about patients as shareholders. And that’s the way it should be.
This story was provided by Market One Media for commercial purposes. Postmedia had no involvement in the creation of this content.