Nemaura Initiates US FDA Studies, and Reports Positive Interim Data from Home-Use Portion of Study
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive glucose trending device for use by persons with diabetes and pre-diabetics today announced it has initiated the first of a number of planned studies in support of a submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product, and further announced positive interim results from the home-use portion of this initial study.
The interim results evaluated data from 25 patients, split approximately equally between Type I and Type II diabetics, each wearing sugarBEAT whilst going about their daily home/work routine for 1 or 2 non-consecutive days, for a total of 36 patient days. Each patient recorded up to 5 finger prick readings per day, at approximately equal intervals, over periods up to 14 hours. Readings were measured using the Abbott Freestyle Optimum neo Blood glucose meter (BGM).
The results analysed 121 matched pair points between the BGM and sugarBEAT®, and indicated 84.3% of the data points had an overall MARD (Mean absolute relative deviation) of 10.63%, and an overall nominal MARD of 16.3% (compared with 14.8%, 16.3% and 18% for Eversense, Dexcom G5 and Abbott Libre Pro respectively*). It is the first time the company has published data from a home use study, which replicates all the challenges of real-world usage, and the data compares favorably to existing CGMs.
The initial U.S. study is expected to enroll a total of 75 patients wearing the device over a 7-day period, including 3 days in a clinical setting (525 total patient days; 225 total in-clinic days). Initial U.S. study completion and FDA submission is anticipated in Q1 2019, alongside poster presentation at ATTD in Berlin in February 2019 for the in-clinic portion, which is designed to record approximately 16,000 matched data points.
SugarBEAT® is expected to launch in the UK, followed by other territories upon achieving CE approval, which is anticipated in the coming months.
*Further detailed summary of the results are available on the publications page of the company’s website.
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible glucose trending device for use by persons with diabetes and pre-diabetics.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals.
SugarBEAT® can additionally be used by insulin using persons with diabetes as an adjunctive glucose monitoring device when calibrated by a finger stick reading.
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® 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.
Nemaura Medical Inc.
Chief Business Officer
The Ruth Group