BETA
Clinical-stage developer of an implantable neurostimulation system for chronic migraine.
ShiraTronics is a privately held medical device developer working on a fully implantable migraine therapy system. Its current website lists St. Paul, Minnesota; earlier announcements describe Minneapolis. The system places pulse generators and leads beneath the skin of the head to stimulate occipital and supraorbital nerve targets. It remains investigational and is not commercially released.
The company is advancing its RELIEV-CM2 randomized pivotal study toward a planned FDA PMA submission. A June 2026 announcement reported enrollment closure with 300 participants across 28 U.S. and Australian sites and 146 implants. The older registry entry lists active, not recruiting, and an estimated 250 participants; those figures reflect different reporting dates. Trial participation is research activity, not commercial adoption.
Evidence includes a small, single-arm pilot study and conference presentations. The company reported a 9.6-day mean reduction in monthly headache days at 12 months, but uncontrolled pilot findings do not establish comparative effectiveness. ShiraTronics announced a $66 million Series B in 2024 and reported $108 million raised by June 2026. It also reported Category III CPT codes effective January 2027; those codes do not establish payer coverage or payment.
The Migraine Therapy System remains investigational. The company reports Breakthrough Device designation in 2021 and an FDA-authorized IDE pivotal study, with a planned PMA pathway. Neither Breakthrough designation nor IDE study permission is FDA clearance or approval to market the device. [24][28][22][20][2]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [9][5]
Latest recorded source review: 2026-10-20.
No commercially released products. The investigational system appears under Commercial development.
NCT06167655: registry status active not recruiting in the 2026-04-14 update; 250 participants (estimated). Study completion is estimated for 2031-05; this is not an FDA decision or commercial launch date. [12]
Implantable stimulators and leads designed to deliver targeted stimulation to nerve pathways associated with chronic migraine. The system’s safety and effectiveness are being evaluated in clinical studies.
Investigational · Not commercially releasedThe company reported 300 enrolled participants across 28 sites and 146 implants. The earlier registry estimate remains 250; no pivotal outcome conclusions are drawn. [28]
The company reported five Category III CPT codes accepted in February 2026, effective January 1, 2027. Coding does not establish coverage, payment, FDA approval or clinical endorsement. [28]
The company reported a 9.6-day mean reduction in monthly headache days. The small, uncontrolled pilot requires confirmation in a larger randomized study; no unanticipated adverse events is not equivalent to no adverse events. [27]
The company reported first implants in the U.S. and Australia in RELIEV-CM2. The trial is investigational and does not establish commercial availability. [24]
Norwest Venture Partners led the round. Announced participants included Seroba, OSF Ventures, Global BioAccess Fund, an undisclosed strategic investor and returning investors. Proceeds were intended to support the pivotal study and potential commercialization. [30]
The company announced Robert (Rob) Binney's appointment as Chief Executive Officer. [20]
ShiraTronics announced FDA Breakthrough Device designation for its chronic migraine neurostimulation therapy. Designation is not marketing approval. [20]
The company announced a $33 million Series A financing, co-led by USVP, Amzak Health and S.H.I.P. [23]
Accessed 10/29/2026