Nemaura Medical Announces Filing of Application for FDA Pre-Submission Program for sugarBEAT® System
13th October 2015, Loughborough, UK. Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive wireless CGM (Continuous Glucose Monitoring) system known as sugarBEAT®, announced today that it has submitted an application under the FDA Pre-submission Program to confirm the Classification of their CGM for the US market.
The sugarBEAT® CGM System is designed to display real time glucose readings on the device and on a mobile phone app via blue tooth, or allow retrospective evaluation of the data. Nemaura has patents covering the device’s ability to self-calibrate using an internal standard concept, eliminating the need for routine daily finger prick calibrations.
The company plans to conduct clinical studies in the first half of 2016 in the US. In light of the minimally-invasive nature of their technology, the retrospective evaluation device is anticipated to be classified as a Class II medical device, therefore potentially shortening the route to market in the US.
About Nemaura Medical, Inc.
Nemaura Medical is developing the sugarBEAT® System as a non-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.
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