NeuWire Medical has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) application for STROKE-REWIRE, a pivotal study evaluating the ReWire vagus nerve stimulation (VNS) system in patients with chronic ischaemic stroke and upper-limb dysfunction.
This prospective, multicentre, randomised, sham-controlled study will enrol up to 135 participants across up to 12 US clinical sites. Study initiation is expected in the first half of 2027, subject to institutional review board approvals and site readiness.
The investigational ReWire system combines a miniaturised, wireless, battery-free implant with closed-loop technology that monitors limb function to automatically pair VNS with successful rehabilitation movements. This approach is designed to strengthen the neural pathways involved in those movements, and support enhanced recovery of arm and hand function.
According to a NeuWire press release, this IDE approval advances years of research at the company and the Texas Biomedical Device Center at UT Dallas (Dallas, USA) into a pivotal clinical study.
“We founded NeuWire Medical to help patients regain function and independence after stroke,” said Rob Rennaker, founder and chief executive officer (CEO) of NeuWire. “For people living with upper-limb dysfunction after chronic ischaemic stroke, everyday activities—such as eating a meal or getting dressed—can remain significant challenges. The ReWire system is designed to pair stimulation with successful rehabilitation movements to support recovery. FDA approval of the IDE allows us to rigorously evaluate whether this approach can help patients regain meaningful motor function and greater independence.”
STROKE-REWIRE will evaluate the safety and effectiveness of the ReWire system. Its primary efficacy endpoint is the change from baseline in the Fugl-Meyer assessment-upper extremity (FMA-UE) score—a measure of upper-limb motor impairment—assessed after completing 18 in-clinic rehabilitation sessions. The study will compare the changes in this score between participants receiving active VNS paired with rehabilitation and those receiving sham stimulation paired with rehabilitation.
Participants will be followed for two years to assess long-term safety, the durability of any observed improvements, and changes in arm and hand function during at-home use of closed-loop stimulation.
“NeuWire is already attracting strong interest, and FDA IDE approval adds substantial momentum at a defining stage for the company,” stated Ramin Mousavi, executive chairman of NeuWire. “With a pivotal study now approved, we have a compelling milestone to build on as we advance our Series A financing. We expect this progress to deepen investor engagement and expand opportunities for strategic partnerships. Our priority now is to translate that momentum into disciplined execution of STROKE-REWIRE, generating the clinical evidence needed to bring ReWire closer to patients and realise its potential to restore function and independence.”
