Nexstim PLC said the U.S. FDA provided a positive response to its proposed limited size trial protocol for its NBT stroke rehabilitation system.
Data from the new trial will be combined with data from the previous phase 3 trial in accordance with the FDA recommendation. The FDA also stated that Nexstim's new sham coil design is appropriate for the new trial.
The response provides Nexstim the possibility to start the new 60-patient trial in the first quarter of 2017.
Nexstim expects the trial to be completed in the first quarter of 2018 and expects to receive de novo 510(k) clearance from U.S. FDA in the fourth quarter of 2018. This clearance will allow Nexstim to start marketing and selling its stroke rehabilitation system in the U.S.