Ray Dirks Research/CPReports

Global Rollout of LabStyle Innovations' Dario Diabetes Management Platform Brings $12 Billion Market Into the Digital Age


New York, NY -- (ReleaseWire) -- 04/09/2015 --Israel–based LabStyle Innovations Corp. (DRIO) combines a smart phone with the need to manage a disease that is reaching epidemic proportions – namely diabetes – and what you get? A block buster product that is simple and elegant that uses the patients' own smart phone to monitor and manage diabetes.

The company has just begun the global rollout of its Dario Diabetes Management System. This product is about to transform the daily management of diabetes, while doing so, it's an opportunity for investors to participate in the up side.

Dario is a platform that combines an all-in-one blood glucose meter, smart phone application for Apple and Android devices, website application with treatment tools to support more proactive and better informed decisions by patients, doctors and healthcare systems. The stylish and compact self-monitoring system combines a lancet to obtain a blood sample, a proprietary disposable test strip cartridge and a smartphone-driven glucose meter. In addition, Dario provides patients, caregivers and clinicians both real-time and historic patient data resulting in better patient performance and improved health. The smart phone is now a glucose monitor.

With no cure yet available to eradicate diabetes, management of the disease is a growing market. More than 382 million people are living with diabetes worldwide and the number is expected to grow to 592 million by 2035.

The global blood glucose monitoring market is expected to reach $12 billion by 2017. The total cost of diabetes in the United States alone was $245 billion in 2012. The nascent market for mobile health monitoring and diagnostics was worth an estimated $650 million in 2012, dominated by cardiac monitors that work in conjunction with smart phones. According to Transparency Market Research, this market is expected to grow at a CAGR of 43% to $8 billion by 2019, led by growth in the mobile glucose monitoring segment. Although $8 billion is a healthy number, two other research firms have published far larger numbers, with Grand View Research estimating the market at $49 billion by 2020 and BCC Research puts it at $21.5 billion by 2018. As the Apple watch is set to launch this month, we are now living in an era when wearable and mobile technology integrate into every other part of our lives including disease management.

LabStyle Innovations is going after this market with its proprietary, market-leading Dario system. Dario offers millions of diabetics a way to self-manage their disease and thrive by monitoring their activities and managing their blood sugars. The U.S. Patent and Trademark Office granted LabStyle a patent covering core functions of the Dario. The company is pursuing patent applications in multiple countries covering the specific processes related to blood glucose level measurement.

Dario just launched in the United Kingdom, New Zealand, Netherlands, and Australia, resulting in LabStyle reporting its first revenues from the product in its recent earning release for the period ended December 31, 2014. It plans to launch in Canada and Italy in the second quarter. In addition to launching in these key markets, LabStyle has diligently pursued reimbursement from payers, and received reimbursement approval in the United Kingdom, Australia and Italy. Management knows having a great product is the key to regulatory approval and market acceptance, but getting paid is paramount.

In addition to reimbursement for the Dario platform from insurance companies or governmental payers, LabStyle also expects multiple additional revenue streams from service fees for diabetes behavioral programs designed to improve clinical outcomes. Data will also be monetized through meta-analysis for insurers, tele-care providers, and clinical study platforms.

Dario has already received regulatory approval in Europe, and FDA approval in the U.S. is expected this year. LabStyle has publicly reiterated as recently as March 25th that it expects to launch Dario in the U.S. in 2015. Management's confidence may stem from results of a recently completed clinical study of 368 patients in the U.S. The study results showed that usability of the Dario Diabetes Management Solution is simple and intuitive. Data from the study indicates that Dario is highly comparable to its predicate device and in fact surpassed other glucose meters. This is exactly what the FDA is looking for in a 510k application for device approval.

The company in my opinion is highly undervalued. At these current prices, it is a great opportunity to potentially get 10x times your money. I recommend putting a small portion of one's risk capital into this stock, which has significant triggers upcoming with U.S. FDA approval and U.S. market launch expected in 2015.

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