CAESAREA, Israel, May 14, 2015 /PRNewswire/ — LabStyle Innovations Corp. (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.