CAESAREA, Israel, March 18, 2015 /PRNewswire/ -- LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, today reported that it has concluded a 368 patient user performance study on the Dario. The results showed that usability of the Dario Diabetes Management Solution is simple and intuitive. The accuracy of Dario has proven to surpass other glucose meters and delivers accuracy that exceeds the minimum new stringent guidance of the ISO 15197:2013.
The successful clinical study is an important milestone, it allows the completion of the 510(k) application for Dario and is a significant step towards the Dario anticipated approval and commercialization in the USA.
The comparative, observational, single-arm User Performance Evaluation study was performed in Columbus Ohio, USA and consisted of 368 subjects having Type I or Type II diabetes. The study was conducted using the Dario all-in-one blood glucose monitoring solution indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The objectives of the study were to evaluate the performance of blood glucose levels taken from the Dario meter compared to the industry's standard references for usability and performance. The study criteria was derived using a combination of the European ISO-15197:2013 In Vitro Diagnostic Test Systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus standard as well as the FDA's more stringent draft guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use document issued on January 7, 2014.
LabStyle also announced the addition of Mr. Bill McGrail to its management team as VP Regulatory. Mr. McGrail brings to Dario over 25 years of experience in the medical device industry particularly new product development of blood glucose meters and regulatory and quality affairs for clearance and distribution of medical products in the U.S., European Union, Canada and a number of other foreign markets. Mr. McGrail is a valuable strategic addition to the Dario team and will lead and support Dario through the regulatory approval process as well as the anticipated introduction to the US market.
In previous roles, Mr. McGrail served as VP of Research and Development for AgaMatrix Inc., where he was responsible for the design and development of state of the art blood glucose meters. As VP of Regulatory, Quality and Clinical, he was responsible for the worldwide clearance of the blood glucose meters and fully integrated mobile health manager apps.
Erez Raphael, president and chief executive officer of LabStyle Innovations, stated "We are very pleased with the results of this important study. The successful study shows that the Dario™ Blood Glucose Monitoring System is highly comparable to its predicate device and can be a valuable tool to the US diabetic community. Mr. Raphael continued; "We welcome Bill McGrail to our management team. We are confident that his vast experience and knowledge in the area of blood glucose meters, their regulation and global distribution will accelerate our regulatory approval and distribution roadmap."
About LabStyle Innovations
LabStyle Innovations Corp. (OTCQB:DRIO) develops and commercializes patented technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle's flagship product is the Dario™ Diabetes Management Solution. Dario™ empowers people with diabetes to take charge of their health with the right tools, insights, and support in their pocket. With access to both real-time and historical blood glucose data, Dario™ is designed to spot patterns, recommend the right treatments and support behavior change efforts.
Dario™ is a platform that combines an all-in-one, blood glucose meter, smart phone application (iOS & Android), website application and treatment tools to support more proactive and better informed decisions by patients, doctors and healthcare systems. The stylish and compact self-monitoring system combines a lancet to obtain a blood sample, a proprietary disposable test strip cartridge and a smartphone-driven glucose meter. LabStyle Innovations is led by an experienced management team with vast software, medical device and technology experience and guided by a world class board of directors and scientific advisory board. For more information: www.myDario.com and http://myDario.investorroom.com.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of LabStyle Innovations Corp. (the "Company") related thereto contains 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. 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.
Contacts:
Press
Brenda Zeitlin
LabStyle Innovations
1 800 896 9062
Brenda@mydario.com
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SOURCE LabStyle