Caesarea, Israel -- (SBWIRE) -- 03/16/2016 -- LabStyle Innovations Corp., developer of the Dario™ Blood Glucose Monitoring System, announced today the national availability of Dario in the U.S. The U.S. rollout follows the U.S. Food and Drug Administration's 510(k) clearance of the Dario in December 2015. The Dario made its U.S. debut at Medtrade's home medical equipment/durable medical equipment trade show earlier this month in Las Vegas, where it was well received by industry participants and distributors interested in selling the product to their customer base.
Direct-to-consumer sales through LabStyle's U.S. website at http://usa.mydario.com/shop are now available and supported through a U.S. based customer service center and hotline. LabStyle's membership-based pricing for direct-to-consumer test strip sales offers users a very cost-effective and convenient solution. The Dario App is now also available through the App Store and ready for download by users across the U.S. Sales through various non-exclusive third party distributors and medical equipment suppliers are anticipated over the first half of 2016.
Through its U.S. headquarters in Massachusetts, the Company is working with insurers to establish reimbursement and arranging agreements with distributors. Product orders for the U.S. market are being processed and shipped through a fulfillment center in California.
"The U.S. is the world's largest market for glucose monitoring and the launch of national availability represents a transformative achievement not only for Dario, but more importantly for users," said Erez Raphael, Chairman and CEO of LabStyle Innovations.
"Our unique ability to deliver a user-centric approach to monitoring glucose levels and other important behavioral factors will help usher in a new era for diabetes management in the U.S., delivering significant value to users, healthcare providers and the entire American healthcare system," added Todd Durniak, LabStyle's Executive Vice President and General Manager for North America.
The Dario Blood Glucose Monitoring System consists of an all-in-one Smart Meter that plugs directly into smartphones coupled with a robust, real-time mobile app, that allows users to track and monitor data such as: blood glucose measurements, carbs and insulin intake, as well as physical activity directly on their mobile devices, making diabetes data management much simpler. Additionally, users can share this data with their community, family and medical staff.
The Dario app integrates with popular apps such as RunKeeper, helping diabetics better manage exercise and fitness activities, and FatSecret, which allows for better food intake management. Instantly generated, personalized reports help users better understand why their blood glucose levels may change.
In keeping with Dario's user-centricity, the company has also focused on a new business model that will revolutionize the way people with diabetes acquire strips. Dario's exclusive membership program will allow people to sign up to a simple and hassle-free program which will deliver the right quantity of strips to their door, every 90 days at competitive prices.
Dario is a leading pocket-sized all-in-one diabetes management solution that provides users all over the world with important disease management features such as emergency hypoglycemia contacts, actionable insights and easy information sharing with medical staff. This technology is now available for people with diabetes in the USA.
About The Dario
The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Dario is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
The Dario Blood Glucose Monitoring System consists of a device housing that includes a blood glucose meter and lancing device. The system also includes test strips, lancets, control solutions and a mobile application. The Dario meter does not require coding or separate batteries. The Dario meter is powered via the 3.5mm audio headphone jack of the smart mobile device. Users are instructed to insert the test strip into the meter, apply the blood or control solution to the test strip, after which the meter will process the test in approximately six (6) seconds and display the test result on the smart mobile device screen via the mobile application.
The Dario Blood Glucose Monitoring System uses Apple's iOS smart mobile device technology to view the glucose test results via a mobile application. This application is available for download via the smart mobile device's application store.
About LabStyle Innovations
LabStyle Innovations Corp. creates innovative mobile and digital tools that empower and engage users to lead healthier lives. LabStyle's "Real time. Real improvements. Real People." approach and strategy is positioning the company as a major player in the mHealth industry. LabStyle's flagship product is the Dario™ Blood Glucose Monitoring System. Dario™ received U.S. FDA clearance in December 2015 and received Europe's CE mark certification in September 2013.
For more information, the content of which is not part of this press release: http://www.mydario.com and http://mydario.investorroom.com.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of LabStyle Innovations Corp. (the "Company") related thereto contains or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when the Company says that sales through various non-exclusive third party distributors and medical equipment suppliers are anticipated over the first half of 2016 and that the Company is working with insurers to establish reimbursement and arranging agreements with distributors.. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.