Miraculins: Pioneering a New Approach to Diabetes Screening
January 27 2015 - 7:00AM
InvestorsHub NewsWire
Winnipeg, CA - January 27,2015 - InvestorsHub NewsWire -
Diabetes affects nearly 30 million U.S. citizens – or roughly 10%
of the population – with about 27% of those cases going
undiagnosed, according to the American
Diabetes Association. As well, there are approximately 80
million Americans estimated to be pre-diabetic, with 90% being
completely unaware of their condition. With about 70,000 deaths in
2010 alone, diabetes is the seventh leading cause of death in the
U.S. and that figure could be dramatically understated given the
chronic under-diagnosis of the disease. [1] As well, diabetes and
its related complications accounted for $245 billion USD in
total medical costs and lost work and wages in the U.S. in 2012.[2] More than 500
million people worldwide are expected to be affected by diabetes by
the year 2030, making it the 7th leading cause of death in the
world. [3] [4]
[EMBED VIDEO: http://vimeo.com/115975028]
Early detection and treatment of diabetes can decrease the risk of
developing many complications associated with the disease, ranging
from nerve damage (seen in half of all diabetics) to high blood
pressure (which can lead to cardiac arrest and stroke).
Unfortunately, traditional diabetes testing is rarely done during
annual physicals because of its invasive nature in requiring a
blood draw and analysis, and 40%-60% of patients in the U.S. are
noncompliant with blood test orders from their physicians due to
cost or fear of needles. [1][8]
In this article, we’ll take a look at Miraculins Inc. (TSX-V: MOM)(OTC: MCUIF)and its non-invasive diabetes screening
test that takes just 90 seconds to complete. It has the potential
to affect real change by making early diabetes screening available
without the need for needles, blood draw, fasting, or waiting and
by creating a tipping point for action, motivating patients at risk
to seek medical care and attention.
Brief History
Miraculins
is a pre-revenue biotechnology
company that acquires, develops and commercializes new,
non-invasive diagnostic and risk assessment tests. However, it began as a research
and development company in 2002, with a focus on biomarker
discovery using its BEST Platform™. In June of 2008, the company
shifted its focus to diagnostic asset development where it began to
in-license and acquire diagnostic and risk assessment technologies
that had completed early stage research and addressed significant
unmet medical needs in the U.S., Canada, and global markets.
[5]
In August 2013, the company completed its
acquisition of its flagship Scout DS®
non-invasive diabetes screening technology from VeraLight
Inc. [6] The innovative technology added to its existing
portfolio, which also includes the PreVu®Non-Invasive Skin
Cholesterol Test - a new clinical tool to aid in coronary artery
disease risk assessment.
PreVudetects cholesterol levels in the
skin - a new biomarker for risk of coronary artery disease - with
similar ease. Elevated
levels of skin cholesterol (cholesterol that has deposited and
diffused into skin tissue as opposed to circulating freely in the
blood stream) have been clinically shown to be associated with an
increased risk of coronary artery disease. Tissue cholesterol
comprises of 11% of total body cholesterol, and the
PreVu® Test painlessly scans cholesterol levels in the
skin. Like the Scout DS®, it doesn’t require needles, blood draw, fasting
or wait times and individuals with elevated test results are
recommended to follow-up with their physician for formal risk
assessment.[9] PreVu® is Health Canada and FDA
cleared and is CE-Marked for the EU.
While the company is largely focused on its Scout DS® technology,
there are many irons in the fire that could unlock long-term value
for shareholders. A successful rollout of the Scout DS® and PreVu®
technology could not only create profitable distribution channels
for the Company, but also ones that Miraculins could use to rollout
future diagnostic/risk assessment products taking a similar
approach to the market as well. [10]
Scout DS® Technology
The Scout DS® is a diabetes screening device that uses visible
light to fluoresce and detect biomarkers in the skin associated
with pre-diabetes and type 2 diabetes.
The skin contains proteins with sugar
molecules attached to them called Advanced Glycation End-Products
(AGE’s) that form as we age, but there are more of them present
when we can’t process blood sugars properly. In short, they
fluoresce when excited by specific light waves emitted by the Scout
DS® device, and this is then detected by the device’s
sophisticated sensor apparatus and captured by its camera. The
Scout DS® painlessly
scans a patient’s skin for AGE’s - along with a series of other key
biomarkers - and then generates a numerical result after running
more than 200 data points through a complex and proprietary
algorithm that determines one’s level of risk for pre-diabetes or
type 2 diabetes based on all the clinical studies that have been
done.
Individuals with elevated scores are
then recommended to see their physician for confirmatory blood
testing. The process can take as little as 90 seconds to complete
and doesn’t involve the use of needles, blood work, lengthy wait
times, fasting, or an initial appointment with one’s physician.
It’s completely non-invasive, with patients conveniently and
painlessly placing their forearm on the Scout DS®
device, and it is the only effective and highly-sensitive,
non-invasive screening technology
available for diabetes risk assessment in the world.[7]
With a CE Mark in the EU and Health Canada clearance the Scout DS®
device is ready to be commercialized in a number of key end
markets. Management plans to file pre-submission documentation with
theFDA regarding the de novo classification as a next step
in securing marketing clearance in the U.S.
In China, where the company has an existing sales and distribution
agreement in place, management expects Chinese FDA approval to take
about one and a half years to materialize. This approval would
trigger initial and minimum orders and commercialization in the
world’s most populous country and potentially unlock significant
long-term shareholder value over the coming years. [10]
Commercialization
The Company’s commercialization strategy includes leasing and
selling medical devices and consumables to hospitals, clinics and
physician’s offices; retail testing through stand-alone kiosks in
pharmacies/grocery chains; and workplace health screenings.
Pharmacies and grocery chains are expected to be quite responsive
in that the average pre-diabetic and diabetic patient can generate
up to $800 and $3,000 per year in revenue, respectively, and
workplace screenings can additionally
help companies better manage their employees’ health and wellness,
realize lower disability and medical claims, and enhance
efficiencies. [10]
Miraculins’ Scout DS® technology is ready to be commercialized in
several different countries around the world. The company’s sales
and distribution agreement in China with Catalyn Medical
Technologies Ltd. - worth up to USD$90 Million over the course of
the agreement’s five year term - will see Scout DS® devices
distributed by Cachet Pharmaceutical Co. A successful rollout in
North America and Europe could further add to the potential over
both the short-term and long-term. [7]
In the long term, the Company intends to build its case for
reimbursement in multiple markets, and believes that CPT codes
already exist in the U.S. to cover the Scout DS® test in
physician’s offices, on procurement of FDA clearance for the
device.
Looking Ahead
Miraculins Inc. (TSX-V: MOM) is uniquely positioned within the
diabetes segment and could be worth a second look for small-cap
investors in the space. While competitors like LipoScience Inc.
(NASDAQ: LPDX) are focused on taking different approaches to detect
insulin resistance early on, the Miraculins’ technology represents
one of the only opportunities for retail-level testing and
multi-channel penetration.
Investors in the small-cap diabetes space, including OTC product
developers like Hi Tech Pharmacal Co. (NASDAQ: HITK), may want to
take a closer look at the stock given its unique technology and
upcoming commercial prospects.
For more information, visit the company’s website at www.miraculins.com.
Safe Harbor Statement:
Matters discussed in this press release contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. When used in this press release, the words
"anticipate," "believe," "estimate," "may," "intend," "expect" and
similar expressions identify such forward-looking statements.
Actual results, performance or achievements could differ materially
from those contemplated, expressed or implied by the
forward-looking statements contained herein. These forward-looking
statements are based largely on the expectations of the Company and
are subject to a number of risks and uncertainties. These include,
but are not limited to, risks and uncertainties associated with:
the sales of the company's identity protection software products
into various channels and market sectors, the issuance of the
company's pending patent application, and the impact of economic,
competitive and other factors affecting the Company and its
operations, markets, product, and distributor performance, the
impact on the national and local economies resulting from terrorist
actions, and U.S. actions subsequently; and other factors detailed
in reports filed by the Company.
Sources
1. http://www.diabetes.org/
2. http://www.cdc.gov/features/diabetesfactsheet/
3. http://www.lunenfeld.ca/about-us/lunenfeld-spotlight/diabetes--disease-of-the-21st-century-will-affect-approximately-500-million-by-2030
4. http://www.who.int/mediacentre/factsheets/fs312/en/
5. http://www.miraculins.com/
6. http://www.miraculins.com/press_releases.aspx?id=184
7. http://www.miraculins.com/pdf/corporate%20factsheet.pdf
8. http://money.cnn.com/2014/10/16/technology/theranos-elizabeth-holmes/index.html?hpt=hp_t2
9. http://prevu.com/
10. Conference Call Notes
Source: UPTICK Newswire