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AMA CPT Editorial Panel Acceptance of Five Category III Codes Establishes Coding Infrastructure for Bilateral Supraorbital-Occipital Neurostimulator Services Ahead of Anticipated Regulatory Submission

MINNEAPOLIS, June 2, 2026 /PRNewswire/ — ShiraTronics, Inc., a clinical-stage medical device company developing neuromodulation therapies for chronic migraine, today 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. Arriving within the same window, the two developments point in the same direction. Patients and physicians completed pivotal enrollment at pace, signaling real demand for a new approach; the AMA, working independently, codified the procedure as distinct clinical work. Together they mark growing recognition of an emerging category, Implantable Extracranial Neuromodulation Systems (IENs) — of which the investigational ShiraTronics system is the first device purpose-built for chronic migraine.

ShiraTronics, Inc., a clinical-stage medical device company focused on developing novel neuromodulation therapies for chronic migraine, today announced compelling 12-month follow-up data from its RELIEV-CM Pilot Study. The findings demonstrate sustained reductions in headache frequency and severity, continued improvement in migraine-specific quality of life, and a consistently favorable safety profile, underscoring the long-term potential of the company’s investigational, fully implantable Migraine Therapy System.

Shiratronics: Addressing Chronic Migraine Head-On

ShiraTronics, inspired to improve upon an off-label treatment, a Minneapolis-based start-up offers chronic migraine patients a dedicated solution for individuals impacted by this disabling condition.

MedTech STRATEGIST JULY-AUGUST 2025 | Vol. 12, No. 7 (Reprinted with permission)

First Implants of Innovative Device Completed in the United States and Australia

ShiraTronics, a clinical-stage innovator in neuromodulation technology, today announced the initiation of its U.S. Food and Drug Administration (FDA) – approved Investigation Device Exemption (IDE) pivotal trial, the RELIEV-CM2 Clinical Study. The first implants of ShiraTronics neuromodulation therapy for Chronic Migraine have been completed in the United States and Australia, marking a new chapter in the company’s efforts to develop innovative solutions for individuals impacted by this disabling condition.

ShiraTronics, a clinical-stage medical device company developing neurostimulation therapies for chronic migraine patients, today announced the closing of a $66 million Series B financing. The round was led by new investor Norwest Venture Partners, with participation from additional new investors Seroba., OSF Ventures, the Global BioAccess Fund and an undisclosed strategic investor. Returning investors U.S. Venture Partners, Amzak Health, Treo Ventures and Aperture Venture Partners also participated in the round.

ShiraTronics, a trailblazing clinical-stage neurostimulation company, proudly presented findings from its Australian Pilot Study, RELIEV-CM, at the American Society of Pain and Neuroscience (ASPN) Pain Conference. This pioneering study showcases the world’s first fully implantable neurostimulation system specifically engineered for chronic migraine.

ShiraTronics, Inc., a pioneering clinical-stage medical device company, today proudly announced the successful conclusion of enrollment in their pilot study conducted in Australia for their minimally invasive, implantable migraine therapy.

ShiraTronics, Inc., a trailblazing clinical-stage medical device company, today announced a landmark achievement with the successful implantation of its Chronic Migraine System in the world’s first six patients. This remarkable milestone represents a significant leap forward in neuromodulation, as the company unveils the first-ever fully implantable system for head location utilizing a minimally invasive approach.

ShiraTronics, Inc., a pioneering medical device company, today announced the initiation of its groundbreaking RELIEV-CM pilot study in Australia, marking the world’s first seven patients’ successful completion of trial phase procedures for their Chronic Migraine Therapy System. This development underscores the company’s commitment to advancing innovative solutions that provide relief and improved quality of life for the millions of individuals who endure the burdens of chronic migraine disease.

Along its journey to treat chronic migraine patients, ShiraTronics raised $5 million as an extension to its Series A funding.

The capital helps the Brooklyn Park-based startup as it embarks on its first in-human studies, which is currently underway in Australia and is expected to conclude late this year or early next year.