Nemaura Medical (NSDQ:NMRD) said today that it launched a study of its wearable glucose monitor in the hopes of winning regulatory approval in the U.S.
The England-based company touted positive interim data from the study, focusing on the at-home use of the sugarBeat device.
The company’s interim results included findings from 25 patients with either Type 1 or Type 2 diabetes who wore the sugarBeat product for one or two non-consecutive days. Each participant also recorded up to five blood glucose readings via finger-pricks per day.
Researchers in Nemaura’s study found that data from the sugarBeat product compared favorably with data gleaned from commercial continuous glucose monitors.
The company’s U.S. study is slated to enroll 75 people who will wear the device over a 7-day period. Nemaura said it expects to finish the study and submit an application to the FDA in the first quarter of 2019.
The company also noted that it anticipates winning CE Mark approval for its sugarBeat device in the coming months.
NMRD shares were trading at $2.76 apiece in mid-afternoon activity today, up 19.8%.
