Nemaura Medical Announces Successful Interim Results For Sugarbeat European Clinical Trials
Published: Sep 21, 2017
LOUGHBOROUGH, England--(BUSINESS WIRE)--Nemaura Medical Inc. (OTCQB: NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free glucose monitoring system today announced interim clinical trial results for the sugarBEAT® European clinical trial programme.
This clinical trial programme consists 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. The trials are expected to determine safety, accuracy, precision and utility of sugarBEAT® as an adjunct to finger stick testing, and is expected to be completed over the next ten weeks.
Interim results based on 175 patient days completed thus far have detected no skin irritation or serious adverse events. Minor adverse events were reported in the form of skin-patch de-lamination due to high humidity weather conditions, and were addressed by using an over-strip of adhesive or use of elastic arm band. Nemaura anticipates launching sugarBEAT® in the UK shortly after completion of this clinical trial programme.
The data generated thus far has indicated accuracy that is comparable to, and non-inferior to that previously achieved by the wired wrist worn predecessor SugarBEAT® device, which received a CE mark in 2016.
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 the wireless sugarBEAT® disposable adhesive skin-patch as a non-invasive, needle-free, pain-free and affordable glucose monitoring system for adjunctive use by diabetics. For more information, please visit www.nemauramedical.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® CGM system, 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