Nemaura Medical Inc., completes second FDA Pre-submission meeting and appoints Navigant to submit IDE for Nemaura’s sugarBEAT® system
4th August 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 that it recently held a second pre-submission meeting with the FDA to discuss the clinical program for its sugarBEAT® system, for the purpose of a PMA submission in the USA. As a result of its meeting, Nemaura’s management has determined a clear direction for the clinical program and has appointed Navigant (NYSE: NCI) to develop the Investigational Device Exemption (IDE) application to submit to the FDA for approval, prior to commencement of the clinical program.
Nemaura Medical anticipates completing the clinical program and submitting the PMA application around mid 2017. SugarBEAT® differs from existing CGM’s because it’s comprised of 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.