UK-based Nemaura Medical Inc (NASDAQ:NMRD) announced Tuesday that it has successfully completed the clinical studies needed to support a De Novo submission to the US Food & Drug Administration for approval of sugarBEAT, the world’s first painless non-invasive glucose monitor.
For certain low-risk novel devices, the FDA's De Novo pathway offers a swifter route to market.
The FDA created the De Novo process in 1997 as an alternative pathway for companies bringing novel Class I and Class II devices to market via the pathway. The goal is to bring more transparency and predictability for manufacturers.
SugarBEAT is targeted at people with Type I and Type II diabetes, as well as for screening prediabetic patients.
The global addressable market for continuous glucose monitoring devices is estimated at $82 billion annually.
"The De-Novo 510(k) route is a potentially shorter pathway to regulatory approval for sugarBEAT, compared to a Pre-Market Authorization (PMA), and a submission next quarter to the FDA could mean we may even be able to launch in the US by the end of 2019 (FDA approval permitting),” said Faz Chowdhury, CEO of Nemaura Medical.
“Given the US represents more than 50% of the world market by value, this is immensely significant,” added Chowdhury.
According to the Centers for Disease Control and Prevention, more than 100 million Americans have diabetes or prediabetes, the precursor to diabetes marked by higher than normal blood sugar levels.
The clinical studies to support the upcoming FDA De Novo submission was split between Type I and Type II diabetics and consisted of 75 patients who were monitored over 225 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 three non-consecutive days for each patient.
The study design was based on two previous meetings Nemaura held with the FDA, ensuring the study was sufficiently powered to provide statistically valid results. Overall the clinical study results indicated a mean absolute relative difference (MARD) of 11.92% (with a lower figure denoting greater accuracy) for 95.95% of the paired data points, using a single point finger prick calibration. There was no device-related adverse event.
Nemaura plans to publish a detailed summary of the clinical data results on its website in the coming weeks, and to submit an application to the FDA during the first quarter of 2019, following the completion of a non-clinical human factors study with 15 end users.
Breakthrough medical technology
Since sugarBEAT doesn’t require needles or insertion it is likely to disrupt the continuous glucose monitor (CGM) device market. It will challenge entrenched players like DexCom Inc (NASDAQ:DXCM), which markets the Dexcom G6 and Abbott Laboratories (NYSE:ABT) Libre System.
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. The innovation of sugarBEAT lies in its groundbreaking skin-patch technology, which allows for better glucose management.
SugarBEAT which has been honed and perfected over seven years is expected to receive CE approval in the UK over the next few weeks. It will launch first in UK and then the rest of Europe and Qatar.
With sugarBEAT, Nemaura is sizing up a $3 billion European market opportunity for CGM devices. The advanced glucose monitoring device could prove a boon for 3.7 million people aged 18 or older who are living with diabetes in the UK.
A predecessor sugarBEAT device from Nemaura, which was based on a wired wrist-watch form factor, received CE Mark approval in 2016.
Chowdhury, a serial inventor and entrepreneur, is the brains behind sugarBEAT. The pharmaceutical scientist received his PhD in Nanomedicine from the University of Oxford. Today, Chowdhury holds 50 patents on drug delivery systems and sensors, across 15 technology platforms.
Contact Uttara Choudhury at [email protected]