LabStyle Innovations Receives Health Canada Approval for Commercialization of the Dario Diabetes Management Solution
Dario turns your smart device into your personal glucose meter - now to be made available for people with diabetes in Canada
May 14, 2015
CAESAREA, Israel, May 14, 2015 /PRNewswire/ -- LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, has announced today that it has been granted Health Canada approval to market and sell Dario™ in Canada through their exclusive distributor in Canada Auto Control Medical Inc. ("ACM"). ACM is a Canadian leader in the category of medical devices for home use, and has successfully launched several blood glucose monitoring systems into the Canadian market over the years. Health Canada is Canada's federal department responsible for helping Canadians maintain their health and the Health Canada approval is a major milestone representing the first sales of Dario in North America.
"Health Canada approval marks an important next step as we continue to expand the geographic reach of the Dario Diabetes Management Solution to the world's huge population of people with Diabetes in order to help make their lives simpler while treating their chronic condition," said Erez Raphael LabStyle Innovations President and Chief Executive Officer. "We are confident that Dario will be well received in North America as it has been in Europe and we are moving forward towards clearing FDA approval for Dario in the U.S."
"We are very pleased to be the exclusive distributor of Dario™ in Canada and will begin aggressively marketing it immediately," said Mr. Robert Burgy, ACM's President. It is reported that an astonishing number of over 20 people every hour of every day are diagnosed with diabetes in Canada, and it is estimated that there are approximately two million Canadian diabetics, 10% of them with Type 1 diabetes. "We believe that both patients and physicians stand to benefit from Dario's unique features. It is anticipated that patients will welcome a better understanding of their chronic condition and self-management as a means to thrive with diabetes, while physicians and caregivers will appreciate the ability to facilitate clinical decisions through quick, easy and effective intervention."
The Company previously announced that it has completed and submitted the submission for FDA review with the results from the successful clinical study performed in the US. The study results showed 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.
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, please visit www.myDario.com and http://myDario.investorroom.com. the content of which is not incorporated by reference into this press release.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of LabStyle Innovations Corp. (the "Company") related thereto contain 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. For example forward-looking statements are being used in this press release when we discuss expanding the geographic reach of the Dario Diabetes Management Solution, when we discuss Dario being well received in North America, when we discuss moving forward towards clearing FDA approval for Dario in the U.S., or when the benefits of Dario to patients and physicians are being discussed. 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 of our products, product demand, market acceptance of our product in Canada by both patients and physicians, the impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of our sales and marketing efforts in North America, 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 "Risk Factors" section and elsewhere in the Company's annual report on Form 10-K for the year ended December 31, 2014 and in subsequent 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.
Press and Investor Relations
1 800 896 9062
SOURCE LabStyle Innovations Corp.