You are here
Nemaura Reports Positive Interim Data from Clinic Portion of SugarBEAT® FDA Clinical Trial
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 persons with diabetes and pre-diabetics, today reported data from an interim analysis of 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.
The interim results consisted of 25 patients, split approximately equally between Type I and Type II diabetics1. The study was conducted in a clinic setting, and blood samples were taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days, for a total of 75 patient days. Blood samples were measured using an Architect c8000 Laboratory Instrument.
9,371 data points were analysed in total, consisting of 4,630 and 4,741 paired data points analysed using 1-point and 2-point calibration respectively. The MARD (Mean Absolute Relative Deviation, @ 30%/30mg/dL) for the 1-point calibration was 12.19% (80% of all data), and for the 2-point calibration the MARD was 10.65% (88% of all data)). The results are in line with the company’s expectations, and compare favorably with competitor products.
SugarBEAT® is expected to launch in the UK in the coming months, and is expected to be marketed to all categories of diabetics, including Type 1, Type 2 and pre-diabetics. Continuous Glucose Monitoring (CGM) is estimated to have a global total addressable market worth $82Bn. The U.S. has the largest number of CGM users, where 2018 usage numbers are estimated at 630,000 insulin users, representing 2.6% of 24.6 million people who have been diagnosed with diabetes.2
Nemaura previously reported data from the home-use portion of the same study, whereby 121 matched pair points between the Blood Glucose Meter and sugarBEAT® were evaluated, which indicated 84.3% of the data points had an overall MARD 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 respectively1).
Completion of U.S. study and FDA submission is anticipated in Q1 2019, alongside poster presentation at the Advanced Technologies & Treatment for Diabetes (ATTD) conference in Berlin in February 2019 for the full in-clinic portion, which is designed to record approximately 16,000 matched data points.
1Further detailed summary of the results are available on the publications page of the company’s website.
2As 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) for use by persons with diabetes and pre-diabetics. 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
The Ruth Group