LOUGHBOROUGH, England. Nemaura Medical Inc. (NMRD), a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, today published clinical data from its recently completed study intended to support a De Novo submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product.
The global addressable market for CGM is estimated at $82B per annum, with the U.S. the largest single market estimated at $13B. CGM adoption amongst people with diabetes is minimal and growing rapidly, with the U.S. having an estimated 2.6% (630,000 users) of all diagnosed diabetics using CGM in 2018, representing annualized growth of 117%.(1)
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The results from the recently completed clinical study consisted of 75 patients, split approximately equally between Type I and Type II diabetics. Blood samples were taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days, for a total of 225 patient days, and measured using an Architect c8000 Laboratory Instrument.(2)
Over 12,000 paired data points were analysed using 1-point and 2-point calibration respectively, using a predictive algorithm. MARD +/-20% or +/- 20mg/dL (76% of paired data) was 8.02% for the single finger prick calibration and 7.96% (78.7% of all data) for the 2-point calibration.
The results are in line with the company’s expectations, and compare favorably with competitor products. A De Novo application is planned to be submitted to the FDA in Q1 2019. A video showing how sugarBEAT® can track glucose levels can be viewed by clicking on the link below.(3)
- As stated in PiperJaffray DXCM Company Note Sep 5th 2018
- Further detailed summary of the results are available at http://nemauramedical.com/publications/
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use sugarBEAT® when calibrated by a finger stick reading.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals.
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
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