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Nemaura Successfully Completes Clinical Studies for SugarBEAT® FDA De-Novo 510(k) Submission
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 reported that it has successfully completed the clinical studies needed to support a De-Novo 510(k) 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. market estimated at $13.5B. CGM adoption amongst people with diabetes is minimal and growing rapidly, with the U.S. the largest single market, with an estimated 2.6% (630,000 users) of all diagnosed diabetics using CGM in 2018, representing annualized growth of 117%.1
SugarBEAT® has the potential to differ from current CGM products and capture significant market share, given it is non-invasive, affordable and flexible. A video showing how sugarBEAT® can track glucose levels can be viewed by clicking on the link below.2
The clinical studies used to support the upcoming FDA De-Novo 510(k) submission were split approximately equally between Type I and Type II diabetics, and consisted of 75 patients over 225 patient days. The studies generated over 12,000 paired data points, with blood samples taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days for each patient.
The study design was based on two previous pre-sub meetings Nemaura held with the FDA, ensuring the study was sufficiently powered to provide statistically valid results.
Overall the clinical study results indicated a MARD (Mean Absolute Relative Difference) of 11.92% (with a lower figure denoting greater accuracy) for 95.95% of the paired data points, using a single point finger stick calibration. There were no device related adverse events. Nemaura plans to publish a detailed summary of these clinical data results on its website in the coming weeks, and to submit an application to the FDA during Q1 2019, following completion of a non-clinical human factors study with 15 end-users.
Nemaura has established the De-Novo 510(k) to be the most appropriate regulatory approval pathway for sugarBEAT®, and expects this route to be a potentially shorter pathway to regulatory approval for sugarBEAT®, as compared to a Pre Market Authorization (PMA).
The recent De-Novo and subsequent 510(k) by Dexcom provide evidence that current FDA thinking on invasive CGM devices for non-adjunctive use are suitable for Class II classification. The non-invasive nature of sugarBEAT®, as an adjunctive CGM, provides a low level of risk as compared to invasive CGMs. Moreover, the risks to health are understood, and appropriate general and special controls have been applied through the ISO 13485:2016 design controls to provide evidence of assurance of safety and effectiveness.
SugarBEAT® is currently undergoing CE review and approval is anticipated in the coming weeks, followed by initial launch in the UK. The UK market for CGM is estimated at 1.38B per annum.2
2 As stated in PiperJaffray DXCM Company Note Sep 5th 2018
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: 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 to better manage their glucose levels. 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 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