LOUGHBOROUGH, England--(BUSINESS WIRE)--
Nemaura Medical Inc. (NMRD), a medical technology company developing the wireless sugarBEAT® non-invasive glucose monitoring system for adjunctive use by persons with diabetes today announced positive summary data for its sugarBEAT® European clinical trial program.
The summary results were taken from a 25 patient cohort of the previously reported European three-stage 75 patient Clinical study, consisting of 80% Type 1 and 20% Type 2 Diabetics. The study was designed as a single centre open-label, single arm, within-subject comparison of sugarBEAT®, with blood samples drawn from a venous catheter at corresponding time points, with glucose concentration measured using a Laboratory blood glucose analyser, ARCHITECT C8000. Each patient continuously wore sugarBEAT® for 14 hours on seven consecutive days. Three of the seven days were in-clinic where venous blood samples were taken at 15 minute intervals over a continuous 12 hour period.
Results indicate an overall MARD (Mean Absolute Relative Difference) of 13.76% over a broad dynamic glucose concentration range. However, up to 70% of the data from the study paired between sugarBEAT® and the venous blood glucose concentration achieved an average MARD of 10.28%, denoting even greater accuracy. A MARD of 10% is deemed to be sufficient for making therapeutic decisions. No serious or major device related adverse events were noted.
CEO, Dr Faz Chowdhury commented, “these results are a significant milestone towards commercialization of sugarBEAT®. We anticipate our miniature wireless device format, which is directly adhered to the body using a non-irritant soft silicone gel, together with our improved sensor performance, will prove to be a formidable tool in helping persons with diabetes globally to better manage their blood sugar levels. We also believe the non-invasive nature of sugarBEAT® will lend itself well to the rapidly growing consumer wellbeing market, for lifestyle glucose management by non-diabetic and pre-diabetic persons.”
SugarBEAT® consists of a disposable skin-patch connected to a rechargeable transmitter, with a mobile app displaying glucose readings at regular five minute intervals. Unlike the Dexcom or Abbott Libre devices, sugarBEAT® is non-invasive and does not require the insertion of a needle-like sensor into the skin.
SugarBEAT® is expected to launch in the UK, followed by other territories upon achieving CE approval, which is anticipated in the coming months. Additional clinical studies are planned for sugarBEAT® for FDA approval in the US, and for use of sugarBEAT® in critical care settings.
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible glucose monitoring system for adjunctive use by persons with diabetes. SugarBEAT® consists of a disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings. For more information, please visit www.NemauraMedical.com and www.SugarBEAT.com.
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.