The company has successfully completed enrolment in its supplementary Phase III clinical trial, known as E-FIT (ELECTRIC FIELD NAVIGATED 1HZ RTMS FOR POST-STROKE MOTOR RECOVERY TRIAL), evaluating the use of Nexstim’s NBT system in upper extremity motor rehabilitation following stroke.
The supplemental trial is being conducted at five clinical centres in the US and has recruited its planned total of 60 patients. The E-FIT trial uses a new sham comparator and has been designed to provide data to supplement the completed Phase III NICHE trial, which demonstrated positive results in the active group, with 2/3 patients showing a clinically meaningful response. Active group data from the Phase III NICHE trial will be pooled with data from the E-FIT trial in the planned filing with the FDA.
Completion of the E-FIT trial is expected in mid-2018, following which Nexstim will file a de novo 510k with the FDA. Approval of this filing by the FDA would allow Nexstim to commercialise its’ NBT system for stroke rehabilitation in the US.
“We are extremely pleased to announce completed patient enrolment in our E-FIT trial, an important landmark on the way to commercialisation of NBT® for stroke rehabilitation in the US. With this announcement, we confirm trial completion is expected in mid-2018, following which we intend to file a de novo 510k for FDA clearance,” said Martin Jamieson, Chairman and CEO, Nexstim Plc.