Two-year-old LabStyle Innovations Corp. (OTCQB:DRIO) made the shift from an R&D-stage company to a commercial enterprise with CE Mark approval in the European Union to market its smartphone diabetes management system, the Dario all-inclusive blood glucose monitoring device and mobile data management system.
The mobile app is also a stand-alone program that LabStyle plans to offer to users of other glucose monitors, according to a company statement. The device maker is also hoping to accelerate its FDA 510(k) submission efforts, after which LabStyle will focus on regulatory submissions in Asia and South America.
News of the approval sent DRIO shares up nearly 4% in mid-morning trading, going for $2.80 as of about 11:40 a.m. today.
Israel-based LabStyle is planning a "soft launch" of the Dario system in the coming months, hoping to gather user feedback among European patients and to "refine its longer-term roll-out strategy."
The Dario blood glucose monitoring device includes a lancet, a disposable test strip vial and a glucose reader adaptor that both holds the strips and interfaces with the mobile app. The app features a blood glucose data log, insulin recommendations and analysis and data sharing tools, the company said.
LabStyle’s "key target populations" include Type I diabetics as well as insulin-dependent Type II diabetics who have to test their blood glucose levels multiple times daily.
"Our strategy is to commence an initial launch of Dario and gain critical feedback from the market, which we will use in tandem with our partners to further refine our design, marketing and intellectual property programs as we advance to full commercial sales over the next 12 months," LabStyle president & CEO Erez Raphael said in prepared remarks. "With CE mark in hand we look forward to accelerating our regulatory approval process in the U.S. and elsewhere during the remainder of 2013."