NeuWire Medical Announces FDA IDE Approval for STROKE-REWIRE Pivotal Study in Chronic Ischemic Stroke

Study will evaluate the ReWire Vagus Nerve Stimulation System™, which combines a wireless, battery-free implant with closed-loop technology designed to pair stimulation with rehabilitation to support recovery of arm and hand function

DALLAS--(BUSINESS WIRE)--NeuWire Medical today announced that the U.S. 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 System in patients with chronic ischemic stroke and upper-limb dysfunction. The prospective, multicenter, randomized, sham-controlled study will enroll up to 135 participants across up to 12 U.S. 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 miniaturized, wireless, battery-free implant with closed-loop technology that monitors limb function to automatically pair vagus nerve stimulation 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.

The IDE approval advances years of research at NeuWire Medical and Texas Biomedical Device Center at UT Dallas 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 of NeuWire Medical. “For people living with upper-limb dysfunction after chronic ischemic 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—Randomized Evaluation of a Wireless Implant for Recovery Enhancement after STROKE—will evaluate the safety and effectiveness of the ReWire system. The 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, measured after completing 18 in-clinic rehabilitation sessions. The study will compare the changes in this score between participants receiving active vagus nerve stimulation paired with rehabilitation and those receiving sham stimulation paired with rehabilitation. The FMA-UE assesses upper-limb motor impairment.

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,” said Ramin Mousavi, Executive Chairman of NeuWire Medical. “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 realize its potential to restore function and independence.”

The IDE approval authorizes use of the ReWire system in the approved clinical study. It does not authorize commercial sale, and the safety and effectiveness of the ReWire system for the proposed indication have not been established.

About NeuWire Medical

NeuWire Medical develops implantable neuromodulation technology to integrate recovery with daily life. Building on research from the Texas Biomedical Device Center at UT Dallas, the company is advancing the ReWire system for patients with chronic ischemic stroke and upper-limb dysfunction. Its investigational technology is designed to pair vagus nerve stimulation with rehabilitation to support recovery through targeted neuroplasticity.

For more information, visit neuwiremedical.com.