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Last $0.37 USD
Change Today +0.0498 / 15.56%
Volume 141.9K
DRIO On Other Exchanges
As of 3:32 PM 05/6/15 All times are local (Market data is delayed by at least 15 minutes).

labstyle innovations corp (DRIO) Snapshot

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05/29/14 - $9.05
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11/14/14 - $0.10
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labstyle innovations corp (DRIO) Details

LabStyle Innovations Corp., a mobile health company, develops and commercializes patent-pending technologies providing consumers with laboratory-testing capabilities using smart phones and other mobile devices. Its products include Dario, a system incorporating patented and proprietary technology that combines a software application and cloud-based data services with self-monitoring of blood glucose device consisting of a lancet, a device-specific disposable test strip cartridge and a smart mobile device-driven glucose reader adaptor. The company is pursuing patent applications in various jurisdictions covering the specific processes related to blood glucose level measurement, as well as various general methods of rapid tests of body fluids using mobile devices and cloud-based services. LabStyle Innovations Corp. was founded in 2011 and is headquartered in Caesarea, Israel.

17 Employees
Last Reported Date: 04/8/15
Founded in 2011

labstyle innovations corp (DRIO) Top Compensated Officers

Acting Chairman, Chief Executive Officer and ...
Total Annual Compensation: $147.6K
Compensation as of Fiscal Year 2014.

labstyle innovations corp (DRIO) Key Developments

LabStyle Innovations Corp. Reports Unaudited Consolidated Earnings Results for the Full Year Ended December 31, 2014

LabStyle Innovations Corp. reported unaudited consolidated earnings results for the full year ended December 31, 2014. For the year, the company reported operating loss of $11,358,000 against $13,562,000 a year ago. Net loss attributable to holders of common stock was $16,055,000 against $13,931,000 a year ago. Basic and diluted loss per share was $1.85 against $3.80 a year ago. Revenues were $51,000. Net cash used in operating activities was $8,581,000 against $7,601,000 a year ago. Purchase of property and equipment was $563,000 against $1,400,000 a year ago. LBITDA was $10,320,000 against $12,723,000 a year ago. Non-GAAP adjusted LBITDA was $8,628,000 against $8,499,000 a year ago. Non-GAAP adjusted LBITDA per stock was $0.99 against $2.32 a year ago.

LabStyle Innovations Submits Data to U.S. FDA from Successfully Concluded 368 Patient Clinical Study of Dario Diabetes Management Solution for 510(k) Marketing Clearance

LabStyle Innovations Corp. (DRIO) reported that it has submitted new data to the U.S. Food and Drug Administration for its 510(k) application after successfully concluding a 368 patient User Performance Study on Dario. The study results showed that usability of the Dario Diabetes Management Solution is simple and intuitive. Data from the study indicates that the Dario Blood Glucose Monitoring System is highly comparable to its predicate device and in fact surpassed other glucose meters. Dario delivers accuracy that exceeds the minimum new stringent guidance of the ISO 15197:2013. The successful clinical study and the submission for FDA review is a significant milestone for LabStyle Innovations and a very important step forward to the highly anticipated commercialization of Dario in the US.

LabStyle Innovations Corp. Reports Conclusion of 368 Patient User Performance Study on the Dario

LabStyle Innovations Corp. 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.


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