Caesarea, Israel -- (ReleaseWire) -- 01/26/2016 --LabStyle Innovations Corp, developer of the Dario™ Blood Glucose Monitoring System, today announced it is preparing to launch its FDA-cleared product in the United States in the first quarter of 2016. The national rollout in the U.S. follows the FDA's 510(k) clearance of the Dario in December 2015.
Direct-to-consumer sales through LabStyle's U.S. website, as well as through leading online retailers like Amazon, are slated to begin in the first quarter of 2016, with sales through various non-exclusive third party distributors and medical equipment suppliers expected to commence in the first and second quarters of this year.
An east-coast based North American headquarters for LabStyle and a west-coast based logistics and warehouse center are now being established and are expected to open during the first quarter to serve both the U.S. and Canadian markets. LabStyle is currently working with insurers to establish reimbursement.
"We look forward to the imminent launch of the Dario in the U.S. and expect to begin shipping product in the current quarter. Entering the world's largest market for blood glucose monitoring is an important milestone for LabStyle," stated LabStyle President and CEO Erez Raphael.
Todd Durniak, LabStyle's Executive Vice President and General Manager for North America added, "The reception we've received so far from potential non-exclusive distribution partners including retailers has been overwhelmingly positive. We are building out our U.S. infrastructure and working hard to prepare for launch."
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. develops and commercializes patent-pending technology providing consumers with laboratory-testing capabilities using smart mobile devices. 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. World rollout began in select countries in December 2013. LabStyle is pursuing patent applications in multiple areas covering the specific processes related to blood glucose level measurement as well as more general methods of rapid tests of body fluids using mobile devices and cloud-based services. 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, we are using forward-looking statements when we discuss launching our FDA-cleared Dario Blood Glucose Monitoring System in the United States in first quarter of 2016, or when we discuss sales through indirect third parties in the U.S. to commence in the first and second quarters of this year, or the timing for establishing east-coast based North American headquarters and a west-coast based logistics and warehouse center. 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 (including, without limitation, the timing for and results of the Company's commercial and regulatory plans for Dario™ as described herein) 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.
