Nemaura Announces Completion of SugarBEAT® European Clinical Trial Programme and Positive Interim Results
LOUGHBOROUGH, England–(BUSINESS WIRE)–Nemaura Medical Inc. (“Nemaura”) (OTCQB: NMRD), a medical technology company developing the wireless sugarBEAT® disposable adhesive skin-patch as a non-invasive, affordable and flexible glucose monitoring system for adjunctive use by persons with diabetes, today announced the completion of its sugarBEAT® European clinical trial programme and positive interim accuracy data.
The European clinical trial programme consisted of a total of 525 patient days, comprising 75 patients continuously wearing sugarBEAT® for up to 14 hours per day over 7 consecutive days in a combination of home and clinic settings. Interim results based on all 525 patient days have detected no instances of skin irritation or major adverse events resulting from the device. Interim accuracy results, taken from a cohort of 175 patient days, have indicated MARD as low as 10% over a large dynamic range, with average MARD comparable to accuracy previously achieved by the wired wrist-worn predecessor SugarBEAT® device, which received a CE mark in 2016.
A summary of the full clinical report is due to be published next month alongside CE submission.
SugarBEAT® consists of a disposable skin-patch connected to a rechargeable transmitter, with a mobile app displaying glucose readings at regular five minute intervals.
Further clinical studies are planned including those for FDA approval in the US, and to investigate the use of sugarBEAT® in critical care settings.
About Nemaura Medical, Inc.
Nemaura Medical is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible glucose monitoring system for adjunctive use by persons with diabetes. SugarBEAT® consists of a disposable skin-patch connected to a rechargeable transmitter, with a mobile app displaying glucose readings at regular five minute intervals. For more information, please visit www.nemauramedical.com and www.sugarbeat.com.
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 Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® product, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical and its partners’ ability to develop, market and sell sugarBEAT®, 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 sugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura Medical’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 Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Director of Strategy & Corporate Development