Nemaura Medical has completed the clinical studies required to support a De Novo submission to the US Food & Drug Administration for approval of sugarBEAT non-invasive glucose monitor.
Image: Nemaura shows positive results in studies of sugarBEAT. Photo: Courtesy of Mark Csabai/FreeImages.com
Nemaura Medical stated that the SugarBEAT product has the potential to differ from the present CGM products and capture significant market share, as it is claimed to be non-invasive, affordable and flexible.
The completed clinical studies support the upcoming FDA De-Novo 510(k) submission were split equally between Type I and Type II diabetics and included 75 patients. The studies lasted over 225 patient days.
The two studies generate more than 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 was designed, based on two previous pre-sub meetings Nemaura held with the FDA, to ensure that it was sufficiently powered to offer statistically valid results.
The overall results of the studies showed a 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. No device related adverse events were reported.
The company also plans to publish the detailed summary of the clinical data results on its website in the coming weeks. It plans to submit an application to the FDA in the first quarter of next year, after completing a non-clinical human factors study with 15 end-users.
Nemaura has stated that the De-Novo 510(k) is an appropriate regulatory approval pathway for sugarBEAT and expects this route can be potentially shorter pathway to regulatory approval, as compared to a Pre Market Authorization (PMA).
The non-invasive nature of sugarBEAT offers a low level of risk compared to invasive CGMs, stated the company.
The company estimates that the global market for CGM is at $82bn per annum and the share of US could be as much as $13.5bn. Adopting CGM among people with diabetes is minimal and is growing rapidly, with the US as the largest single market.
In the US alone, there is an estimated 2.6% (630,000) of all the diagnosed diabetes users using CGM this year. This represents an annualized growth of 117%.