LabStyle Innovations Corp (OTCMKTS:DRIO) has reported that its recent study on 368 patients, using Dario Diabetes Management Solution, has returned successful results. The study has found that the device has proved to be user friendly, along with being innovative. Additionally, the results also showed Dario to be much more accurate than any glucose meters out there and it even exceeds the new ISO 15197:2013 guidelines. The success has made it possible for the company to complete its 510 (K) application for the device, after which it would be ready for distribution in the market.
The Study was conducted in Columbus, Ohio, with the subjects having either type I or type II diabetes. The device uses the same method as other glucose meters to draw fresh blood capillaries from the finger tips and uses quantitative measurements for the results. The study was aimed at evaluating performance of blood glucose levels and confirming it with industry standards.
Apart from its new product all set for launch, the company also announced changes in its administration. LabStyle has just appointed its Vice President of Regulatory, Mr. Bill McGrail. Mr. Bill has previous experience with launch of new products, especially with glucose meters. The company aims to use the expertise of Mr. Bill to pass Dario through regulatory bodies and get its approval before introduction to the US market. Previously, Mr. Bill had been working with innovative technologies, such as developing special apps for monitoring of blood glucose.
LabStyle Innovations Corp (OTCMKTS:DRIO) closed at $0.45 gaining a 4.65%. It currently trades 27.92 million shares in the market. In its FY2014, the company had reported $51,000 in revenues, with expenditures amounting to $3.9 million. The net loss for the same year was recorded to be $16 million, which came to $1.85 per share, compared to $3.8 for the preceding year. The company also reported $1.5 million as cash deposits. With the new product ready to break into the market, the company is expected to record a substantial increase in revenue and share value.