Nemaura Medical (Nasdaq:NMRD) announced today that it received Saudi Food and Drug Authority (SFDA) approval for its sugarBEAT sensor.
The company develops daily, non-invasive, disposable, wearable glucose sensors. It also offers digital diabetes management tools and earlier this year added CGM-guided insulin dose titration to its offerings.
Nemaura’s sugarBEAT, a CE-marked device, offers non-invasive, flexible continuous glucose monitoring (CGM). It provides actionable insights derived from real-time glucose measurements and daily glucose trend data. It could help people with diabetes and pre-diabetes better manage, reverse and prevent the onset of the chronic condition.
Loughborough, England-based Nemaura submitted an FDA premarket approval application for sugarBEAT in the U.S. The company also said it filed an application for the reimbursement of sugarBEAT in the UK recently.
According to the company, approval in Saudi Arabia follows a year of liaisons with the SFDA. The company said it represents a “major breakthrough” for commercialization in the Middle East’s regions largest territory. A 2021 report said nearly 4.5 million people (18.3% of the adult population) in Suadi Arabia have diabetes, Nemaura said. That compares to a 9.3% global average.
Nemaura previously announced the receipt of a provisional purchase order for 1.7 million sensors and 17,000 devices from its TPMENA Middle East licensee. The company now plans to work with TPMENA to fulfill the purchase order.
“The Company believes that SFDA approval places Nemaura Medical in an unparalleled position to gain approval across the Gulf and other regions, and to commercialize its digital programs,” Nemaura said in a news release.