ShiraTronics
ShiraTronics is a clinical-stage medical device company developing a fully implantable extracranial neuromodulation system using bilateral supraorbital-occipital stimulation for chronic migraine patients unresponsive to conventional therapies, pursuing FDA PMA after completing its RELIEV-CM2 pivotal trial.
- Company typePrivate
- Founded2019
- HeadquartersMinneapolis, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What ShiraTronics does
ShiraTronics is a clinical-stage medical device company developing an implantable extracranial neuromodulation system (IEN) for the treatment of chronic migraine. Founded in 2019 and headquartered in St. Paul, Minnesota, with a wholly-owned Australian subsidiary (ShiraTronics Australia PTY LTD) used exclusively for clinical investigation, the company targets adults aged 22 or older with migraine for at least 12 months who experience 15 or more headache days per month and have not responded to conventional therapies including Botox. The product architecture consists of two fully implantable stimulators and leads placed beneath the skin near the occipital and supraorbital nerves, delivering mild electrical pulses to interrupt or change migraine pain signals; a handheld charger and headset support weekly recharging. ShiraTronics holds 27 issued US utility patents and one design patent covering the chronic migraine management system.
The clinical program includes the completed Australian RELIEV-CM pilot study (with positive 12-month follow-up data announced in September 2025) and the FDA-approved IDE RELIEV-CM2 pivotal trial, which completed enrollment in June 2026 with 300 participants across 28 US and Australian clinical sites and 146 implanted recipients. ShiraTronics received FDA Breakthrough Device Designation in February 2021 and is pursuing Premarket Approval (PMA), with a planned limited commercial launch post-approval. The American Medical Association CPT Editorial Panel accepted a dedicated five-code Category III set for bilateral supraorbital-occipital neurostimulator services, effective January 1, 2027.
ShiraTronics is pre-revenue with no commercial sales; the device is limited by US federal law to investigational use. Future revenue is expected from hardware sales of the implantable system and associated components following PMA clearance and a planned limited commercial launch targeting headache specialists, pain neurologists, and neurosurgeons. The company has raised $108 million cumulatively, including a $33M Series A (October 2019), a $5M Series A extension (August 2023), and a $66M Series B (October 2024) led by Norwest Venture Partners, with participation from USVP, Amzak Health, Treo Ventures, Aperture Ventures, Seroba, OSF Ventures, Global BioAccess Fund, and earlier investor LivaNova PLC.
ShiraTronics firmographics
Firmographics- Name
- ShiraTronics
- Legal name
- ShiraTronics, Inc.
- Website
- https://shiratronics.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- ShiraTronics is a clinical-stage medical device company developing a fully implantable extracranial neuromodulation system using bilateral supraorbital-occipital stimulation for chronic migraine patients unresponsive to conventional therapies, pursuing FDA PMA after completing its RELIEV-CM2 pivotal trial.
- Ownership category
- akta.pro rank
ShiraTronics industry classification
Industry- Product category
- Implantable Neuromodulation Medical Devices
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Electromedical & Electrotherapeutic Apparatus (3845)
- akta.pro primary industry
- Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK)
Keywords
Where ShiraTronics is headquartered
LocationHeadquarters
- HQ city
- Minneapolis
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
ShiraTronics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
Revenue model
- Implantable Neuromodulation Device Sales: Pre-commercial stage. The company is developing an implantable neurostimulation system for chronic migraine. Once FDA approved, the company plans a limited commercial launch, generating revenue through device sales and associated components (chargers, headsets).
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
ShiraTronics product offering
Product offeringCore offering
ShiraTronics develops an implantable extracranial neuromodulation therapy system — the ShiraTronics Migraine Therapy System — designed to treat chronic migraine through bilateral stimulation of the occipital and supraorbital nerves. The system consists of an implantable pulse generator, neurostimulation leads, and an externally worn controller that enables patient-directed therapy. The product is currently investigational and is being evaluated in the RELIEV-CM2 clinical study for refractory chronic migraine patients.
Product overview
ShiraTronics is a clinical-stage medical device company developing a unified product ecosystem centered on its ShiraTronics Migraine Therapy System, an implantable extracranial neuromodulation device for chronic migraine. The system consists of fully implantable stimulators and leads that deliver mild electrical pulses to occipital and supraorbital nerves, along with a handheld charger and headset for patient use. The clinical program includes the completed RELIEV-CM pilot study and the ongoing RELIEV-CM2 pivotal trial. The company has received FDA Breakthrough Device Designation and is pursuing Premarket Approval. The company raised $108M total as of 2026, with the most recent $66M Series B in October 2024.
Differentiator
Problem solved
Functional benefit
Products and services
- ShiraTronics Migraine Therapy System An implantable extracranial neuromodulation therapy system consisting of an implantable pulse generator, occipital and supraorbital neurostimulation leads, and an externally worn patient controller. It is designed for specialist implantation in patients with refractory chronic migraine who have failed conventional pharmacologic therapy.
Quantifiable outcome
- Positive 12-month follow-up data from RELIEV-CM Pilot Study demonstrating sustained reductions in headache frequency and severity, continued improvement in migraine-specific quality of life, and favorable safety profile
Companies that use ShiraTronics
Customer profileNamed customers1 record
Segments1 record
Ideal customer profiles1 record
ShiraTronics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
ShiraTronics partnerships and signals
Strategic signalScale indicators5 records
Recent moves6 records
Expansion highlights5 records
ShiraTronics competitors and assessment
Company assessmentBroad incumbents
- Boston Scientific: Boston Scientific is a major neuromodulation player (Precision Spectra SCS, Vercise DBS) with established sales infrastructure into pain and neurosurgery specialists. Several ShiraTronics executives have direct Boston Scientific tenure, making it a relevant strategic comparability point.
- Medtronic: Medtronic is the largest player in implantable neurostimulation (SCS, DBS, targeted drug delivery) and is the source of multiple ShiraTronics leaders including the VP of R&D/Manufacturing. It is the natural strategic acquirer or potential entrant into a migraine neuromodulation category.
- Nevro: Nevro is a publicly traded spinal cord stimulation (SCS) company with commercial neuromodulation sales force, payer relationships, and infrastructure that could in theory distribute or compete with migraine-focused neurostim. Relevant as a broad incumbent in implantable neurostimulation.
- Abbott (St. Jude Medical): Abbott acquired Spinal Modulation (where ShiraTronics' co-founder was CTO) for over $500M, giving it Proclaim DRG neurostim and a path into neuromodulation. It is the most directly comparable incumbent relative to the founder's prior exit and the migraine indication.
Emerging players
- Inspire Medical Systems: Inspire Medical commercializes an implantable neurostimulation device (hypoglossal nerve stimulation) for obstructive sleep apnea. While the indication differs, Inspire is a relevant emerging-implantable-neurostim comparable on commercialization playbook, CPT code pathway, and unit economics.
- Saluda Medical: Saluda Medical developed the Evoke closed-loop spinal cord stimulator and recently obtained FDA approval. It is an emerging neuromodulation implant peer at a similar stage of commercialization, providing useful comparables for valuation and adoption ramp.
Direct peers
- Cefaly Technology: Cefaly produces an external trigeminal nerve stimulation (e-TNS) device for migraine prevention. It is a direct competitor in the consumer- and clinician-facing migraine neuromodulation space and often referenced as the incumbent low-cost option ShiraTronics must displace.
- Mainstay Medical: Mainstay Medical developed ReActiv8, an implantable restorative neurostimulation system for mechanical chronic low back pain, and obtained FDA PMA approval. It is highly comparable on regulatory pathway, neuromodulation implant business model, and team overlap with ShiraTronics' VP of Regulatory, who authored ReActiv8's PMA.
- Theranica Bio-Electronics: Theranica develops Nerivio, a prescription neuromodulation device for acute and preventive migraine treatment. It is the closest direct competitor to ShiraTronics in the migraine-specific neuromodulation category, although delivered externally rather than implanted.
- electroCore: electroCore markets gammaCore, a non-invasive vagus nerve stimulation (nVNS) device indicated for migraine and cluster headache. It competes for the same chronic and acute migraine neuromodulation patient pool that ShiraTronics targets with an implantable solution.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights8 records
Customer concentration
ShiraTronics social profiles
Digital presenceShiraTronics financial estimates
Financial estimateRevenue estimate
Valuation estimate
ShiraTronics leadership team
Management profileNumber of profiles
ShiraTronics subsidiaries and ownership
Company hierarchySubsidiaries1 record
ShiraTronics funding detail
Funding detailFunding overview
Funding rounds4 records
Investors10 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ShiraTronics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ShiraTronics
What does ShiraTronics do?
ShiraTronics develops an implantable extracranial neuromodulation therapy system — the ShiraTronics Migraine Therapy System — designed to treat chronic migraine through bilateral stimulation of the occipital and supraorbital nerves. The system consists of an implantable pulse generator, neurostimulation leads, and an externally worn controller that enables patient-directed therapy. The product is currently investigational and is being evaluated in the RELIEV-CM2 clinical study for refractory chronic migraine patients.
Is ShiraTronics a public or private company?
ShiraTronics is a private company. It is classified as venture growth investor backed and is currently operating.
When was ShiraTronics founded?
ShiraTronics was founded in 2019. It employs 11 to 50 people.
Where is ShiraTronics based?
ShiraTronics is headquartered in Minneapolis, United States, in the North America region.
How does ShiraTronics make money?
One revenue line is on record: implantable Neuromodulation Device Sales.
Who are ShiraTronics's main competitors?
Broad incumbents on record are Boston Scientific, Medtronic, Nevro and Abbott (St. Jude Medical). Emerging players are Inspire Medical Systems and Saluda Medical. Direct peers are Cefaly Technology, Mainstay Medical, Theranica Bio-Electronics and electroCore.
Does ShiraTronics have an API?
No public API is recorded for ShiraTronics.
What industry is ShiraTronics in?
ShiraTronics's product category is Implantable Neuromodulation Medical Devices. Its primary akta.pro industry code is HLAHAEAK, Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS). Its NAICS code is 334510 and its SIC code is 3845.