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SOURCE LabStyle Innovations Corp.
600,000 Italians Now Eligible for Reimbursement Coverage
CAESAREA, Israel, April 28, 2014 /PRNewswire/ -- LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, today announced that it has received national approval and regional reimbursement for the Dario™ Personalized Smart Meter in Italy.
Receipt of reimbursement approvals is a key component of LabStyle's continuing commercial roll out of the Dario™ Diabetes Management Solution. The Dario™ Personalized Smart Meter works in tandem with the Dario™ blood glucose and lifestyle monitoring mobile application to form the complete Dario™ Diabetes Management Solution.
Erez Raphael, LabStyle's President and Chief Executive Officer said, "Reimbursement approvals in Italy are a significant milestone as we expand across Europe, bringing advanced care to Italians with diabetes. This endorsement by the regional Italian authorities, recognizing the value of our complete diabetes management solution, is an important milestone in our global reimbursement strategy."
Ugo Cosentino, President of the Dario Italian distributor Harmonium Pharma, stated "We are thrilled that Italians with diabetes can now enjoy this world class smart meter that combines the highest quality glucose meter with personalized information logging and tracking their blood glucose levels and supporting them in the daily management of their glycemia. This innovative solution represents another important milestone to our company mission consisting of accompanying diabetic patients towards an improved quality of life."
According to the International Diabetes Federation, diabetes affects up to 8% of the adults in Italy from the age of 20-79 and it is growing at an alarming rate. The Italian Ministry of Health's determination will enable full reimbursement for Dario™ strips and lancets in the approved regions. Medical device reimbursement approvals in Italy are granted regionally. Dario™ is currently approved for reimbursement in some major regions including Lombardi (Milan), Veneto (Venice), Umbria (Perugia) and Calabria (Reggio Calabria) which enables full coverage for a population of over 600,000 people with diabetes. Additional regional approvals are expected to be granted over the coming weeks.
About LabStyle Innovations
LabStyle Innovations Corp. (OTCQB:DRIO) develops and commercializes patent-pending technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle's flagship product is the Dario™ personalized smart meter. Dario™ received CE mark certification in September 2013 and began a world rollout in select countries in December 2013. LabStyle filed a Premarket Notification Application, also known as a 510(k), with the US Food and Drug Administration (FDA) for the Dario™ smart meter (Dario™ Blood Glucose Monitoring System) 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: 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 and call participants 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 launch of Dario™ in Italy and elsewhere) 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.
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