LabStyle Innovations Corp (OTCMKTS:DRIO) Innovations has confirmed the submission of new data to the Federal and Drug Administration as it moves a step closer to the commercialization of Dario in the US. The submission was made after the conclusion of a User Performance Study on 368 patients.
The company affirms that results from the study indicate that Dario accuracy levels exceeded the minimum stringent guidance of the ISO 15197:2013 with the glucose monitoring system found to be comparable to its predicate device. The positive results mark a milestone for LabStyle Innovations Corp (OTCMKTS: DRIO) and to the diabetic community at large.
Approval in the U.S will be a big achievement for LabStyle Innovations Corp (OTCMKTS:DRIO) Innovations as Dario Blood Glucose Monitoring system has already received marketing clearance in Europe having also launched in New Zealand Netherlands and Australia. The company is now confident that it will receive approval in the U.S which should boost its revenue streams as the glucose monitoring market is expected to reach highs of $12 billion by 2017.
Dario Glucose Monitoring System uses the same method as other blood glucose measuring meters to draw blood from capillaries while using quantitative measurements for results. Things continue to move in a promising direction for the Penny Stock seen by impressive fourth quarter and full year results for 2014. The company is already in a partnership with Israeli prominent HMO Maccabi Healthcare to implement Dario Digital for professionals and patients.
LabStyle Innovations Corp (OTCMKTS:DRIO) Innovations posted net cash of $1.45 million in 2014 with total current assets amounting to $2 million and liabilities of $1.6 million. Net revenue came in at $51,000 with a net loss of $12.8 million. It is also the first quarter that the company recorded its first ever revenue from the sale of Dario.