Nemaura Medical Inc (NASDAQ:NMRD), a UK-based medtech company, on Tuesday published positive clinical data from its recently completed clinical studies supporting 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.
READ: Nemaura completes clinical studies for De Novo submission to FDA for sugarBEAT glucose monitor
"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)," Faz Chowdhury, CEO of Nemaura Medical, told Proactive Investors in a recent interview. "Given the US represents more than 50% of the world market by value, this is immensely significant."
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.
Nemaura plans 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.
Separately, the sugarBEAT maker said it priced a public offering of common stock and warrants with expects proceeds of up to $2.5 million.
More significantly, the capital raise signals Nemaura is all set to launch sugarBEAT, which has been honed and perfected over seven years. The device 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.
“Nemaura plans to use the net proceeds from the offering for a US FDA clinical trial, product launch in Europe and the development of a second generation of sugarBEAT,” the company said in a statement.
The offering was priced at $1.04 per share, with each share coupled with one five-year warrant to purchase one share of common stock, at an exercise price of $1.04 per share.
Dawson James Securities acted as the sole placement agent in connection with the offering.
Nemaura's stock was down sharply to $0.86 per share at midday as investors typically react negatively to news of share dilution. However, savvy investors are aware that with the UK launch, Nemaura which has a market cap of roughly $175 million, will get traction and near-term revenue.
The company still has over $3 million in its kitty and no debt. With the additional capital infusion the medtech company will have ample funds for sugarBEAT's UK launch.
Contact Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive