SOURCE: VantageWire.com - On each of the many forms of the television franchise Star Trek, injured crew are whisked away to sick bay to be attended to by the ship's doctor. By waving a device called a "tricorder" over the patient, the doctor instantly diagnoses the patient, and often times heal them. Though today's doctors are yet to be equipped with their own tricorders, crucial strides towards non-invasive testing and detection are moving us closer to a more pleasant medical experience.
As the baby boomer generation shuffles towards retirement, the value of early detection for potentially serious conditions is increasing. Given that Canada, and in Europe, the retirement age has been bumped from 65 to 67, the need for increased attention to health becomes more essential, as reaching retirement just got two years harder.
Urging people to take care of themselves is a difficult task. Often times, major ailments go undiagnosed due to a multitude of factors, including: inconvenience, time constraints, fear of doctors, needles or bloodwork, and the annoyance of fasting.
Winnipeg-based Miraculins [TSX-V:MOM] is working to address many of these concerns, by bringing the world closer to Star Trek's tricorders.
The company became visible in the Canadian retail pharmacy market with its skin cholesterol test called Pre-Vu® Point-of-Care (POC). The test, which measures cholesterol in the skin as a new biomarker for risk of coronary artery disease, does not involve needles or drawing blood – so no pain or handling of potentially dangerous bio hazardous material is involved. It also doesn't require a tedious fasting period prior to testing.
In addition to PreVu, Miraculins recently announced the acquisition of a non-invasive screening test for diabetes called the SCOUT DS®. With both the Scout DS and PreVu, Miraculins is set to address two serious issues facing communities today— coronary artery disease (CAD) and diabetes— easily and painlessly in your neighborhood pharmacy.
PREVU: SKIN CHOLESTEROL TEST
Miraculins' PreVu has already been tested in select markets in Canada beginning late last year. Much of its visibility came within the well-known London Drugs chain.
Now the FDA has cleared PreVu for sale in the U.S. as well. Miraculins officially announced its new footing in the lucrative U.S. market this July.
The United States' population suffers over 1.5 million heart attacks each year, resulting in over 500,000 deaths. PreVu has the potential to detect risk early, and possibly save lives along the way by alerting the customer in need of special healthcare, attention, and a change of lifestyle.
A new deal with supermarket/pharmacy giant H-E-B (340 stores in Texas and Northern Mexico) has Miraculins' foot in the U.S. door. Now they will potentially have PreVu skin cholesterol testing clinics in as many as 300 stores in Texas, following a 20-store pilot expected to take place in fall 2013.
On top of working towards expanding PreVu in the United States, Miraculins has also has a desire to move into the UK/EU market.
PreVu has been CE-Marked for distribution in the UK and other member states of the European Union. The test's lack of overnight fasting, blood draw, or needles, and ability to flag potential risks early, helps to project PreVu's desirability across several markets.
The test involves the application of harmless reagents to the skin of one's palm which bind with cholesterol first and then subsequently change color. Next comes a scan of the color with a handheld instrument to detect the change. The more intense the color hue, the greater the amount of skin cholesterol present.
After 5 minutes the results are ready, and place the individual on a scale of risk based on the clinical data. The process concludes with a point of care consultation including a review of what the next steps in the risk assessment process (if applicable) might be.
PreVu measures skin cholesterol and is not a replacement for blood cholesterol testing. Skin cholesterol is different than blood cholesterol, is measured differently and as such the PreVu test provides an important new perspective of cholesterol load in the body.
Approximately 11% of the total cholesterol found in the human body, by weight, resides in the skin. Elevated levels of skin cholesterol have clinically been shown to be strongly associated with an increased risk of CAD. While not diagnosing the presence or absence of CAD, PreVu can help identify high or hidden risk patients, and help them address their risk sooner.
SCOUT DS: SCREENING FOR DIABETES
While CAD is certainly a risk many are aware of, given the obesity epidemic, the risk for diabetes is on the rise. Like clinical CAD testing where a full lipid panel is involved, diabetes screening requires fasting for 12 hours, and lab work to draw blood and check glucose levels. At the moment, there are no non-invasive and user-friendly methods available to screen for diabetes.
By definition, screening tests are expected to be easy, quick and painless. With current diabetes testing, if a patient shows an initial positive result for glucose intolerance, they'll be required to take the test again, requiring more fasting and time at the lab.
Screening tests should be low cost, with high throughput, and only take moments to deliver results. It's this mentality that Miraculins followed with PreVu, and it's what they're striving for again with the acquisition of VeraLight's SCOUT DS system, the world's first non-invasive diabetes screening system that's fast, convenient and effective in screening for pre-diabetes and type 2 diabetes.
With $20 million invested into its original technology by Johnson & Johnson, which was focused at the time on fluorescing glucose in the blood, SCOUT was developed further to fluoresce and measure the skin for elevated advanced glycation end products ("AGES") - a sensitive metric for the cumulative damage the body has endured due to the effects of abnormally high blood sugar and oxidative stress.
Much like PreVu, SCOUT DS identifies markers in the skin to assess for risk, but without applications of reagents. The patient merely places their arm on an instrument that illuminates a small patch of skin near the elbow and analyzes the optical signature of AGES. The patient is then placed on a scale of risk based on the clinical data. The technology has already been used and validated by thousands of patients globally.
From an investment standpoint, the SCOUT DS should appeal to all retail pharmacy chains. For these medical merchants, a diabetic patient is worth approximately $5,000 per year. The idea is that if the patient identified the problem in a store, they'll likely shop again at that store for the ensuing medications and related products such as vitamins, health foods and monitoring instruments and supplies.
Already, in some trial runs, pharmacies were giving the test away for free as a screen to identify potential new long-term customers, while some charged $10-$15 per test.
THE BOTTOM LINE
By targeting retailers that want to secure more of the aging baby boomer demographic, and for patients with pre-diabetes and type 2 diabetes, Miraculins has two products that will be more and more visible in stores near you, very soon.
What the market apparently wants to hear is when the revenue is expected. Continued pilot programs are laying the key groundwork for broader product launches, and Miraculins has been taking methodical and sequenced steps toward market expansion. Investors should gain confidence knowing that the company is in this for the long term and is committed to see the technology reach a tipping point.
That said, being a pre-revenue biotech in Canada is tough. What Miraculins has wisely done, is get its foot in the door through approvals and pilots in Canada and the United States, while working towards product distribution in the UK and EU.
If this company were based or even just listed within the US, it could be worth 3 to 4 times its current market cap. With the technology they have in play, more respect for the company's holdings should've been expected. Whereas right now it's amidst a sea of TSX.V pessimism currently witnessed across the entire exchange.
At a certain point, something's gotta give. A new deal in Europe, or H-E-B's greenlight for presence in more stores, could finally be the trigger point that properly puts Miraculins onto investors' maps.
Meanwhile more and more patients are becoming concerned with their health and well-being, while the invasive nature of testing remains an obstacle for many. Miraculins is addressing this challenge on two technology fronts, by inching us closer to eliminating the need to rely solely on blood testing as an initial screen for millions of patients.
PreVu and (even more so) SCOUT DS could be the missing link in healthcare's evolution from bloodletting, through to blood testing, and onward to the Star Trek's tricorder. In the end, the goal for patients, providers, and investors is always to "Live Long, and Prosper."
G. Joel Chury
for the Bottom Line Report
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