LabStyle Innovations Receives Israeli Ministry of Health Approval for the Dario™ Smart Meter
Jul 28, 2014
CAESAREA, Israel, July 28, 2014 /PRNewswire/ -- LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, announced today that it has received approval from the Israeli AMAR for the marketing and sale of the Dario™ Smart Meter in Israel. The Israeli AMAR is a unit in the Ministry of Health and is responsible for certification of all activities concerning medical devices import, sale and export and is a precondition for the sale of medical devices in Israel.
AMAR approval will allow people with diabetes in Israel to soon join the initial Dario™ users in the United Kingdom, Italy, and New Zealand where the initial market launch of the iOS version of Dario™ began in late March 2014. In 2013, LabStyle received CE Mark approval for the marketing and approval of the Dario™ system.
The AMAR approval is the latest milestone in LabStyle's global regulatory strategy. In early 2014, LabStyle announced that it filed a 510(k) application with the U.S. Food and Drug Administration (FDA) to allow for the marketing of Dario™ in the U.S.
The demand for the Dario™ Smart Meter has been very encouraging during the initial soft launch. In addition to its launch locations, LabStyle plans to be marketing Dario™ in 6 additional territories by the end of 2014.
"It has been very rewarding to experience the initial market demand for Dario™ in our soft launch territories, and we are proud of our achievements, including achieving regulatory approval in the country where the idea for Dario was born" said Erez Raphael, LabStyle's President and CEO. "The response in the select launch countries has been incredible and beyond our expectations. We are looking forward to bringing Dario™ to the population of people with diabetes here in Israel in order to help make their lives simpler by easily tracking their blood sugar changes and providing them with control and greater insights into their daily decisions for treating their chronic condition. With Dario™, diabetes management is not only about generating accurate blood glucose measurements but also gathering and providing practical information, analysis and suggestions, including through via social community channels, to help those with diabetes make better informed decisions and improve their lifestyle."
Dario™ is a cloud-based, diabetes management solution which includes novel software applications combined with the stylish, 'all-in-one', pocket-sized, Dario™ Smart Meter which interfaces with a user's mobile device to form the overall Dario™ Diabetes Management Solution, allowing diabetics to monitor their blood sugars and other activities and gain insights into managing their disease using their mobile devices.
The Dario™ App has already been launched in Israel and is available on the App store for iPhones and on Google Play for Android smartphones.
According to the International Diabetes Federation, diabetes affects more than 8% of the adults in Israel from the age of 20-79 and its prevalence is growing.
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, a mobile, cloud-based, diabetes management solution which includes novel software applications combined with a stylish, 'all-in-one', pocket-sized, blood glucose monitoring device. 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 and in April 2014, LabStyle received a Notice of Allowance for a U.S. patent covering core functions of the Dario™™ Blood Glucose Monitoring System. 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 results of the Company's sales, marketing and regulatory efforts with Dario™ in Israel) 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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