Vancouver, BC April 18, 2013 – Diabetes rates in Canada have doubled over the past decade, with one in every three Canadians projected to have either diabetes or pre-diabetes by 2020. The shocking statistics were published this month by the Canadian Diabetes Association, which advised all health care professionals to screen wisely and diagnose precisely to help doctors identify the disease quicker.
The latest figures from the International Diabetes Federation reveal that currently 366 million people have diabetes worldwide, and 4.6 million deaths are due to diabetes. A staggering US$ 465 billion is spent on care for diabetes across the globe. This disease is one of the century’s greatest health challenges and remains on a relentlessly upwards trajectory. Both organizations agree that early and reliable diabetes testing is one measure that could potentially save more lives.
Enter Miraculins Inc., a Canadian medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, which has just announced it has signed a Term Sheet to acquire an innovative non-invasive screening test for diabetes that is already approved for sale in Canada and Europe.
The SCOUT system is the first non-invasive diabetes screening system designed to provide a highly sensitive and convenient method for screening for pre-diabetes and type 2 diabetes based on the presence of diabetes-related biomarkers found in skin. Unlike current screening methods, a SCOUT test requires no blood draw, no fasting, and no waiting for a lab result.
“The SCOUT represents an exceptional opportunity for Miraculins,” says Christopher J. Moreau, Miraculins CEO and president. “It adds to our story and builds on our value equation of offering non-invasive screening technology. We have been in negotiations for some time with the owners to acquire the SCOUT – which is US based.”
Miraculins currently works with products that already have worldwide potential. The company already has two technology programs that have captured the attention of the global healthcare industry because of their unique value.
The first is a skin cholesterol test called PreVu, and the second technology is for a disease called preeclampsia, a devastating and growing disease of pregnancy affecting 5 to 8 percent of women worldwide regardless of ethnicity.
The PreVu Non-Invasive Skin Cholesterol Point of Care Test is a completely painless and non-invasive test, which involves no blood draw or needles, requires no overnight fasting and involves no handling of potentially hazardous biomaterials. The test is conducted on the palm of the hand in less than five minutes with results being immediately available, facilitating point of care consultation and a next steps discussion.
“Skin cholesterol is an important new biomarker in assessing risk of coronary artery disease,” Moreau says. “As such, the PreVu test can serve as a convenient first step in the global risk assessment process, reaching those who have not been assessed, or who avoid blood testing, and providing them with a tipping point for greater personal action and resolve in looking after their heart health.”
Coronary artery disease is a leading cause of death in Canada and a difficult condition to detect. There are more than 7.2 million heart attacks globally every year and growing, and 540 million blood cholesterol tests performed annually worldwide.
Miraculins closed on the PreVu transaction in the fall of 2010. It took the company about two years to get the product ready for market.
“For Miraculins to manufacture and sell a diagnostic device, we needed to become International Standards Organization (ISO) certified, and that took us about a year,” explains Moreau. “Our company had to undergo tremendous change. We were basically a research and development company prior to acquiring the PreVu, and then we had to go through all these significant changes to become certified. It was a great exercise because it forced us a company to make sure that all of our systems and processes were consistent with the international standard.”
The second lead technology Miraculins has developed is for a serious disease of pregnancy called preeclampsia. The disease affects more than 6.4 million pregnancies per year in the US and 134 million worldwide, with a cost of more than $3 billion annually to the global healthcare system.
Preeclampsia’s rapidly progressive condition, characterized by high blood pressure and the presence of protein in the urine, can quickly accelerate and result in seizure, coma, kidney failure and death for both mother and child. The technology was being advanced through a collaborative research and option agreement with Alere, Inc.; one of the world’s largest diagnostic companies with professional and consumer offerings in over 100 disease categories, and a market capitalization of $2 billion. Alere recently licensed from Miraculins the lead marker in the company’s preeclampsia program.
“We were excited to have partnered a key part of our preeclampsia technology with a major international diagnostics company and they are responsible for advancing a test through regulatory approval and on to commercial sales.” says Moreau.
Miraculins business model is to license and acquire business technology that can either be acquired from a research institution or a university, or another company.
“We are one of a handful of Canadian diagnostic companies that have been able to get a product through the regulatory approval process required so that we can begin to start selling,” Moreau says.
“The way we found out about the SCOUT opportunity was through one of our distribution partners in Canada called Pear Healthcare, which represents us in the retail pharmacy market. There are striking similarities with the SCOUT and PreVu. It’s non-invasive and it involves taking a reading of the skin, and even though the two tests are different what I found interesting was that we are looking for a risk marker for heart disease, and the SCOUT is identifying people who are pre-diabetic, since diabetes is also a risk factor for heart disease.”
“In today’s technologically advanced world, tests that are non-invasive will be the future, so it was interesting that PreVu was being represented by Pear Healthcare while they were simultaneously representing the SCOUT,” Moreau says.
Miraculins partnered with Pear Healthcare last year and initially launched a PreVu pilot program with London Drugs, one of western Canada’s leading pharmacy chains, in the fall of 2012. Based on the success of that pilot, London agreed to offer the PreVu test at one day rotating clinics at all of its 76 locations. Miraculins then secured a launch agreement with the 350 store PharmaChoice pharmacy network earlier this year to introduce the PreVu test in Ontario and Atlantic Canada in the spring of 2013, through a Phase One launch in up to 50 of its stores, with the hope of expanding the program to all of the stores in the fall.
“About three months ago we heard that a private US based company called Veralight, the owners and developers of the SCOUT, were having financial difficulty,” Moreau says.
“We reached out to them and we emerged as the lead potential merger and acquisition partner for this technology. A significant factor in having Miraculins considered as a potential acquirer of the Scout is that many of the markets we envision selling the PreVu test into would be identical for the SCOUT. From that context, we think it’s a good fit because we can assume the operational aspects of the SCOUT by only adding incremental costs to our overhead and without dramatically adding to our sales and marketing budget.”
Miraculins is designed to have more than one product. As a medical diagnostic development company, Miraculins has a team of specialists representing different disciplines including: product development, quality control, regulatory affairs, manufacturing, business development and corporate governance.
“We have developed expertise in all of these areas and have structured our operations team in a way that allows us take on more than one product at a time,” Moreau explains.
Miraculins expects to announce the terms of the SCOUT agreement if the company completes definitive documentation, he says.
“Now that the initial term sheet has been approved by the Miraculins board, we are probably talking about 45 to 60 days before definitive documentation could be concluded at which point we would announce the closing of the deal as well as some of the key deal points.”
About Miraculins Inc.
Miraculins is a medical diagnostic company focused on acquiring, developing and commercializing non-invasive tests for unmet clinical needs. A significant number of promising diagnostic opportunities remain un-commercialized because of the sizable gap between the discovery stage, when research institutions are typically involved, and the commercialization stage, when larger commercial enterprises become interested. Miraculins has direct experience in bridging this gap. The Company’s PreVu® technology is a revolutionary new coronary artery disease risk assessment technology that measures cholesterol levels in a patient’s skin non-invasively, painlessly and without the need for fasting. Miraculins is also advancing a suite of biomarkers to aid in the early detection of the devastating disease of pregnancy known as preeclampsia. The lead marker in the Company’s preeclampsia program is partnered with Alere Inc., one of the world’s largest diagnostic companies. For more information visit http://www.miraculins.com.
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