14th April 2016, Loughborough, UK. Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive, needle-free, wireless CGM (Continuous Glucose Monitoring) patch known as sugarBEAT®, today announced further interim clinical data based on increased measurement frequency.
The sugarBEAT® skin-patch is designed to display real time glucose readings on a reader via blue tooth, or allow retrospective data evaluation on a reader or mobile phone App. Nemaura today issued results of an interim study of eight patient day visits, consisting of five Type I diabetics, two of whom made two visits each, and one Type II insulin dependent diabetic patient, with up to 12 hours device wear time per day. Previously Nemaura reported data on over 100 patient days clinical evaluation of the sugarBEAT® system with glucose levels measured once every 20 minutes, thus three times an hour. This study was designed to establish the possibility of measuring glucose levels at five minute intervals, 12 times every hour. The evaluation consisted of 81 paired data points, with a single finger prick calibration, and glucose range between 70-400 mg/dl. The results indicated a MARD of 14.05%, and 75% of the data in Zone A, and over 98% of the data in Zones A and B of the Clarke Error grid. There were no reports of skin irritation or other adverse events.
Nemaura Medical anticipate launching sugarBEAT® in Europe at the end of 2016, and stated that this result provides further confidence in sugarBEAT®, and positions it well amongst current CGM’s.
SugarBEAT® differs from existing CGM’s given it comprises an adhesive daily disposable skin-patch which does not require insertion of a needle-like sensor inside the skin. SugarBEAT® also provides users with tremendous flexibility as to when and how often they choose to wear the patch. Both of these factors are expected to empower users in a way current CGM’s cannot.
About Nemaura Medical, Inc.
Nemaura Medical is developing the sugarBEAT® System as a minimally-invasive, needle-free, 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.
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