Nemaura Medical Present Positive Interim Clinical Trial Results of its sugarBEAT® System
5th October 2015, Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing the sugarBEAT® CGM System as a minimally invasive, wireless continuous glucose monitoring system, announced today that it has conducted a further interim analysis of clinical data from its ongoing 540 patient day clinical program of Type I and Type II diabetic Patients, and have determined a reduction in MARD from 18% to 11.8%. MARD is the Mean Absolute Relative Difference between finger-stick measurements and CGM sensor glucose values; a lower MARD indicates higher accuracy.
Nemaura Medical previously reported an interim evaluation that indicated the primary endpoint of accuracy and secondary endpoint of safety had been met. The current evaluation was taken from a further 76 patient day study, consisting of 19 patients wearing the device on four separate days, for 12 hours per day. The CGM data was compared with blood finger prick analysis using the Hemocu BGM device, up to 3 times per hour. Despite the enhanced results the skin safety profile was maintained without any complaints of adverse skin irritation.
The sugarBEAT® device displays real time glucose readings on the device and on a mobile phone app via blue tooth. Nemaura have patents that allow the device to self-calibrate using an internal standard concept, eliminating the need for routine daily finger prick calibrations. The company plans to submit for CE approval of the device by the end of 2015 and launch in Europe and other select territories by mid 2016 via strategic partnerships and licensees. Nemaura Medical is also currently preparing to file a pre-submission application to the FDA to consolidate their US clinical roadmap and product approval process.
About Nemaura Medical, Inc.
Nemaura Medical is developing the sugarBEAT® System as a minimally-invasive, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements.
Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s sugarBEAT® CGM System, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell the sugarBEAT® System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its sugarBEAT® System.
These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.