Migraine is becoming an increasingly important frontier for neuromodulation. Despite continued progress in pharmaceuticals, many patients still live with a significant disease burden. This is creating room for neurotechnology companies that develop alternatives for patients not finding adequate relief from existing therapies.
One company advancing this approach is ShiraTronics. Earlier this month, the company announced it had completed enrollment in RELIEV-CM2, its investigational device exemption study evaluating an implantable neurostimulation system for chronic migraine. The milestone moves ShiraTronics one step closer to a potential FDA premarket approval submission.
Founded in 2018, Minneapolis-based ShiraTronics has raised approximately $108 million to date, including a $66 million Series B financing completed in October 2024 to support its pivotal trial and regulatory pathway. The company is developing a fully implantable neurostimulator specifically for chronic migraine. The device delivers continuous, low-level electrical stimulation to nerve pathways involved in migraine, with bilateral targeting of the occipital nerve and supraorbital nerve. These pathways sit within the broader trigeminal nerve complex, which plays a central role in migraine pain signaling.
The implant includes no external hardware. Therapy is delivered continuously and can be adjusted by the patient to prevent migraine attacks rather than treat them after onset. ShiraTronics has described the approach as purpose-built for head-based therapy, distinct from earlier systems adapted from spinal cord stimulation. The device is currently being evaluated in RELIEV-CM2, a multicenter, double-blind, sham-controlled study assessing its safety and efficacy in adults with chronic migraine.
The company enrolled 300 participants across 28 sites in the United States and Australia over approximately 18 months. First implants began in late 2024. By the time enrollment was completed, 146 participants had received the implant. The trial focuses on patients with at least 12 months of migraine history who experience 15 or more ‘headache days’ per month, where migraine episodes last more than four hours.
With enrollment now complete, ShiraTronics will now analyse the data from RELIEV-CM2. The central question is whether the trial can demonstrate a clinically meaningful benefit in this patient population. Positive outcomes could support a PMA submission to the FDA and move the company closer to commercialisation.
ShiraTronics’ neurostimulator received FDA Breakthrough Device Designation in 2021, which allows for more interactive review during the regulatory process. Alongside the enrollment milestone, the American Medical Association accepted five new Category III CPT codes covering bilateral supraorbital-occipital neurostimulator procedures. The codes are expected to take effect on January 1, 2027.
Category III codes provide a formal mechanism for tracking utilization and outcomes of emerging procedures. For companies developing implantable neuromodulation devices, coding infrastructure is often an important step toward future reimbursement discussions and broader clinical adoption. In this case, the new codes also help define bilateral supraorbital-occipital neurostimulation as a distinct procedure, rather than a variation of an existing neuromodulation category.
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