Winnipeg, MB -- (SBWIRE) -- 01/27/2015 -- 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]
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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 non compliant 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.
PreVu detects 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 the FDA 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. 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., 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 http://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.
Miraculins Inc.
6-1250 Waverley Street
Winnipeg, Manitoba
R3T 6C6
Phone: 204-453-1408
Fax: 204-453-1546
info@miraculins.com
For Investor Relations Phone 204.477.7599 or ir@miraculins.com
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
Source: UPTICK Newswire