US-based clinical-stage medical device company ShiraTronics has announced two major milestones in the development of its Implantable Extracranial Neuromodulation System (IEN) designed for patients living with chronic migraine.
The company has completed enrollment in its RELIEV-CM2 pivotal clinical trial and also secured acceptance from the American Medical Association (AMA) CPT Editorial Panel for a dedicated five-code Category III CPT set covering bilateral supraorbital-occipital neurostimulator services.
These developments are being viewed as significant progress for the emerging field of Implantable Extracranial Neuromodulation Systems (IENs), with the investigational ShiraTronics system positioned as the first device purpose-built for chronic migraine.
“Two things happened in close succession that, together, mean more than either does alone. The pace of pivotal enrollment told us, directly, that the unmet need is real,” said Rob Binney, CEO, ShiraTronics.
About the Trail
RELIEV-CM2 is a prospective, multicenter, double-blind, sham-controlled pivotal IDE study evaluating the safety and effectiveness of the ShiraTronics system in adults with chronic migraine. The study enrolled 300 participants across 28 clinical sites in the United States and Australia in just over 18 months. According to the company, 146 participants have received implants of the investigational neurostimulation device.
Completion of enrollment now allows the company to advance toward its planned readout sequence and future regulatory submission.
The company said the latest milestones build on the positive results of the earlier RELIEV-CM Pilot Study, which showed clinically meaningful and durable reductions in monthly headache days through 12 months. The study also reported improvements in migraine-specific quality of life and a consistently favourable safety profile with no unanticipated adverse events.
In February 2026, the AMA CPT Editorial Panel accepted five Category III CPT codes for bilateral supraorbital-occipital neurostimulator procedures, which are scheduled to become effective from January 1, 2027.
Joshua Rosenow, a neurosurgeon and investigator in the RELIEV-CM2 trial, said dedicated CPT codes indicate growing recognition of the procedure as a distinct clinical innovation.
“For those of us who implant these systems, that recognition carries real weight. It says the procedure we are evaluating in RELIEV-CM2 is a novel advance, and that the framework to describe it accurately is already taking shape. That is an important step for the field, and for the patients who have been waiting for something genuinely new,” he added.
How ShiraTronics System Works
The investigational ShiraTronics system is a fully implantable neurostimulator designed to deliver targeted stimulation to the trigeminal nerve complex, which is highly implicated in migraine.
According to the company, the system is intended to provide continuous therapy aimed at preventing migraines around the clock, rather than treating attacks only after they begin. Unlike some existing therapies, the device requires no external hardware or wearables to deliver treatment
“Once implanted, it delivers ongoing therapy discreetly in the background of a patient’s life, without the routines or daily effort that many existing options require,” the company said.
Samer Narouze and Brian Grosberg, national co-principal investigators of the RELIEV-CM2 study, noted that many people with chronic migraine remain inadequately served despite the real advances of recent years.
“Completing pivotal enrollment in a rigorous, randomized study of this design is a significant step, and the engagement we saw across sites reflects how much need remains for new, evidence-based options,” they added.
Headquartered in Minneapolis, Minnesota, ShiraTronics received FDA Breakthrough Device Designation in 2021 and has raised $108 million to date. The company is now preparing for future study readouts and plans to pursue Premarket Approval (PMA) from the US Food and Drug Administration, followed by a limited commercial launch pending regulatory review.
