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Nemaura Reports Positive Zero Finger-Stick Calibration Data for SugarBEAT® Continuous Glucose Monitor
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: 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 announced data indicating sugarBEAT® could potentially be used as an adjunctive CGM without the need for finger-stick calibration.
Nemaura retrospectively evaluated a portion of previously completed clinical data for 75 patients (337 in-clinic patient days), using a refined factory calibration constant, based upon newly developed algorithms. 66% of patches worn by 92% of the patients generating 9,863 paired data points were evaluated, with 58% of these paired data points giving a MARD of 13.61%. Nemaura further noted 73% of these paired data points gave a MARD of 17.83%.1
Nemaura is currently undertaking additional data analysis, to potentially allow sugarBEAT® to be used with zero or reduced frequency finger-stick calibration.
Nemaura previously published an interim data set on September 12, 2018, from an in-clinic portion of a FDA study which indicated a MARD of 12.19% (at 30% / 30mg / gL) was achievable (on 80% of all data) with a single finger-stick calibration, and a MARD of 10.65% was achievable (on 88% of data) with two finger-stick calibrations, over a 14 hour wear period.1
Current CGM adoption is minimal and growing rapidly amongst people with diabetes, with the global total addressable market estimated at $82Bn annually. The U.S. is the largest single market, with CGM being used by an estimated 2.6% (630,000 users) of all diagnosed diabetics in 2018, representing annualized growth of 117%.2
SugarBEAT® is anticipated to launch in the UK in the coming months, and is intended to be marketed to all categories of diabetics, including Type 1, Type 2 and pre-diabetics.
1 Further detailed summary of the results are available on the publications page of the company’s website.
2 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical Inc.
Nemaura Medical (NASDAQ:NMRD) is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to provide people with diabetes and pre-diabetics with an Ambulatory Glucose Profile (AGP) as a superior metric to better manage their glucose levels as compared to an HbA1c reading. Insulin users can adjunctively use sugarBEAT® when calibrated with a finger-stick glucose 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 for periods up to 24 hours.
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