LabStyle Innovations Reports Dario Blood Glucose Monitor Demonstrates Over 99% Accuracy in New Study
Reported in poster presentation at Diabetes Technology Meeting on October 22 and 23, 2015
Oct 29, 2015
LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, today announced results from a recent performance accuracy study of the Dario™ Blood Glucose Monitoring System. Data was presented by Dr. Paul Rosman, who serves on LabStyle's Scientific Advisory Board, at the 15th Annual Diabetes Technology Meeting in Bethesda, Maryland which took place on October 22-23, 2015.
The poster titled "Performance of a Smart Phone Linked Blood Glucose Assessment Platform" presented data which showed the Dario™ meets new International Standards Organization (ISO) 2013 performance requirements for accuracy and with excellent precision results.
"LabStyle is very proud of this study's results. Over 99% accuracy, which meets and exceeds ISO standards, shows our Dario™ Diabetes Management Solution is not only user-friendly for patients, caregivers and doctors, but most importantly it is incredibly accurate and reliable," stated LabStyle CEO Erez Raphael. "We believe we are bringing blood glucose monitoring and the management of diabetes into a new era, driven by connected mobile technology platforms."
In the accuracy study, 78 adult diabetes patients donated 100 fresh whole blood capillary samples. The samples were tested with three different test strip lots. Each lot was tested by 2 different meters and compared with a Yellow Springs Instrument (YSI) glucose analyzer at values between 50 and 400 mg/dL. This assessed glucose measurement at pre-specified glucose levels in conformance with ISO 2013 guidelines. Further, comparative analysis was reported with the YSI standard on a Consensus Error Grid analysis and revealed 100% results within zones A and B, in compliance with ISO 2013 acceptance criteria.
The precision study was performed in accordance with ISO 2013 guideline using venous whole blood samples. Five different glucose concentrations and 3 Dario test strips lots were tested. The study demonstrated excellent results which exceed the acceptance criteria, indicating excellent precision performance for Dario BGMS.
About LabStyle Innovations
LabStyle Innovations Corp. (OTCQB: DRIO) develops and commercializes patent-pending technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle's flagship product is the Dario™ personalized smart meter. Dario™ received CE mark certification in September 2013 and began a world rollout in select countries in December 2013. LabStyle filed a Premarket Notification Application, also known as a 510(k), with the US Food and Drug Administration (FDA) for the Dario™ smart meter (Dario™ Blood Glucose Monitoring System) in December 2013. LabStyle is pursuing patent applications in multiple areas covering the specific processes related to blood glucose level measurement as well as more general methods of rapid tests of body fluids using mobile devices and cloud-based services. For more information: http://www.mydario.com and http://mydario.investorroom.com the content of which is not part of this press release.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of LabStyle Innovations Corp. (the "Company") related thereto contain or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. For example, the Company is using forward looking statements in this press release when it describes its belief that it is bringing blood glucose monitoring and the management of diabetes into a new era, and when it states that it is pursuing patent applications. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for and results of the Company's commercial and regulatory plans for Dario™ as described herein) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.