LabStyle Innovations launching Dario CGM in Q1

LabStyle Innovations Corp. (OTCQB:DRIO) said Tuesday it is launching its Dario blood glucose monitoring system in the 1st quarter of 2016, through both direct-to-consumer sales and online retailers.

Continued commercialization through non-exclusive 3rd party distributers and medical equipment suppliers is expected through Q1 and Q2 of 2016, the company said. The company is working with insurers in hopes of establishing reimbursements.

“The reception we’ve received so far from potential non-exclusive distribution partners including retailers has been overwhelmingly positive. We are building out our U.S. infrastructure and working hard to prepare for launch,” exec veep and North America GM Todd Durniak said in prepared remarks.

The company said it is establishing an east coast North American headquarters and west coast based logistics and warehouse center to handle the launch, expecting to open both in the 1st quarter.

“We look forward to the imminent launch of the Dario in the U.S. and expect to begin shipping product in the current quarter. Entering the world’s largest market for blood glucose monitoring is an important milestone for LabStyle,” CEO Erez Raphael said in a press release.

In late December,  Labstyle Innovations said it won FDA 510(k) clearance for its Dario blood glucose monitoring system, including its blood test strips and the Dario app for Apple (NSDQ:AAPL) iOS devices.

The system is designed to operate around a smartphone and a small glucose meter that communicates with the phone through the audio jack, the company said. The smartphone as a central device is important to the systems functionality and ease of adopting, Durniak told MassDevice.com in an interview in September.

The small plug-in monitor contains everything necessary to take blood glucose readings, which the Dario platform uploads to cloud-based storage where they can be observed, recorded and shared by caretakers, physicians and others, Durniak said.

Israel-based LabStyle Innovations said the Dario blood glucose monitoring system won indications for the “quantitative measurement of glucose in fresh capillary whole blood samples drawn from the finger tips.”

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