Nemaura Medical Inc (NASDAQ:NMRD) announced Wednesday it has submitted a De Novo medical device application to the US Food & Drug Administration for approval of SugarBEAT, the world’s first painless non-invasive glucose monitor.
The Loughborough, England-based medtech company said it has “successfully completed” the clinical studies needed to support the De Novo submission.
Investors felt the development could speed up sugarBEAT’s arrival in the US, sending Nemaura stock up nearly 8% to 0.95.
For certain low-risk novel devices, the FDA's De Novo pathway offers a swifter route to market.
SugarBEAT is targeted at people with Type I and Type II diabetes, as well as for screening prediabetic patients.
“We are pleased to have submitted our De Novo 510(k) application to the FDA within our projected timelines thanks to our exemplary team of scientists and engineers,” said Nemaura Medical CEO Faz Chowdhury. “The global addressable market for continuous glucose monitors is estimated at $82 billion per year, and over $13 billion in the US alone.”
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.
De Novo submission to FDA
The company said it prepared its dossier for FDA submission by conducting clinical studies which were 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.
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.
"Unlike other devices on the market, as the world’s first non-invasive CGM, SugarBEAT does not puncture the skin to insert a sensor filament inside the skin. Instead the sensor sits on top of the surface of the skin," said Chowdhury. "For this reason, Nemaura believes the total addressable market for SugarBEAT is likely to be far greater at $179 billion, many times larger than the market addressable by the current competition."
Preparing for commercialization
Nemaura said it was talking to medical device distributors in the US.
"The FDA has a structured review process, which should allow the review to be expedited," said Chowdhury. "While waiting for feedback on the application, the company has now started to enter into discussions with key global companies in this space for commercialization in the US.”
SugarBEAT received a CE mark from the British Standards Institute in May and Nemaura Medical plans to launch it in the UK and Germany in the next quarter. This will be followed by launches in other EU countries like France and Italy.
The company also plans to commercialize its CGM in other geographies like the Middle East and Australia that accept CE Mark approval.
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.
—(Updates with details on commercialization)—
Contact Uttara Choudhury at [email protected]