ShiraTronics announced two milestones: the completion of enrollment in its RELIEV-CM2 pivotal trial, and the acceptance by the American Medical Association (AMA) CPT Editorial Panel of a dedicated five-code Category III set for bilateral supraorbital-occipital neurostimulator services.
Together they mark growing recognition of an emerging category, Implantable Extracranial Neuromodulation Systems (IENs) — of which the investigational ShiraTronics system is the first device built for chronic migraine.
"Two things happened in close succession that, together, mean more than either does alone," said Rob Binney, Chief Executive Officer of ShiraTronics. "Special recognition and gratitude to the patients, investigators, and study teams who entrusted us with this work, without whom none of this happens. The pace of pivotal enrollment told us, directly, that the unmet need is real. The AMA CPT Editorial Panel, working from a very different vantage point, reached a parallel conclusion when they accepted a dedicated five-code set for this procedure. One vote from the people living with this disease and the clinicians who care for them. One vote from the institutional infrastructure that defines how medicine recognizes new procedural categories. Our job now is to keep earning the trust both groups have already extended."
The investigational ShiraTronics system is a fully implantable neurostimulator designed specifically for chronic migraine, delivering targeted neurostimulation to the trigeminal nerve complex, which is highly implicated in migraine. Because it is designed to deliver therapy continuously, the system is intended to work to prevent migraine around the clock rather than responding only once an attack has begun. It is a therapy that 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 design intent is straightforward – a therapy that works for the patient rather than asking the patient to work for it.
"As the national co-principal investigators for RELIEV-CM2, we have seen firsthand how many people with chronic migraine remain inadequately served despite the real advances of recent years," said Samer Narouze, MD, PhD, and Brian Grosberg, MD, national co-principal investigators of the RELIEV-CM2 study. "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. We look forward to the data, and to what a purpose-built approach could add to the care of patients who have exhausted much of what is currently available."
ShiraTronics received FDA Breakthrough Device Designation in 2021 and has raised $108 million to date. With pivotal enrollment now complete, the company is preparing for its planned readout sequence and intends to pursue Premarket Approval (PMA) from the FDA, with an anticipated limited commercial launch following clinical results and regulatory review.
