LabStyle Innovations Submits Data to U.S. FDA from Successfully Concluded 368 Patient Clinical Study of Dario Diabetes Management Solution for 510(k) Marketing Clearance

CAESAREA, Israel, March 24, 2015 /PRNewswire/ -- LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, today reported that it has submitted new data to the U.S. Food and Drug Administration for its 510(k) application after successfully concluding a 368 patient User Performance Study on Dario. The study results showed that usability of the Dario Diabetes Management Solution is simple and intuitive. Data from the study indicates that the Dario™ Blood Glucose Monitoring System is highly comparable to its predicate device and in fact surpassed other glucose meters. Dario delivers accuracy that exceeds the minimum new stringent guidance of the ISO 15197:2013.

The successful clinical study and the submission for FDA review is a significant milestone for LabStyle Innovations and a very important step forward to the highly anticipated commercialization of Dario in the US.

"We are very excited to have completed the submission to the FDA. The successful study shows that the Dario™ Blood Glucose Monitoring System is highly comparable to its predicate device and can be a valuable tool to the U.S. diabetic community," stated Erez Raphael, President and Chief Executive Officer of LabStyle Innovations. "The Dario has already received marketing clearance in Europe and has launched in the UK, New Zealand, Netherlands and Australia. We anticipate approval and launch in the U.S. in 2015 where the glucose monitoring market is expected to reach $12 billion by 2017, according to the International Diabetes Federation."

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About LabStyle Innovations

LabStyle Innovations Corp. (OTCQB:DRIO) develops and commercializes patented technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle's flagship product is the Dario™ Diabetes Management Solution. Dario™ empowers people with diabetes to take charge of their health with the right tools, insights, and support in their pocket.  With access to both real-time and historical blood glucose data, Dario™ is designed to spot patterns, recommend the right treatments and support behavior change efforts.

Dario™ is a platform that combines an all-in-one, blood glucose meter, smart phone application (iOS & Android), website application and 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. LabStyle Innovations is led by an experienced management team with vast software, medical device and technology experience and guided by a world class board of directors and scientific advisory board. For more information: 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. 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 (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. 

Contacts:
Brenda Zeitlin
LabStyle Innovations
1 800 896 9062
[email protected]

SOURCE LabStyle Innovations Corp.

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