CEFALY
CEFALY sells an FDA-cleared, over-the-counter trigeminal nerve stimulation device for acute migraine relief and daily prevention, distributed direct-to-consumer via e-commerce and a certified clinician network, with recurring electrode subscriptions and coaching services for individual migraine sufferers.
- Company typePrivate
- Founded2016
- HeadquartersWilton, United States
- Headcount—
- GTM typeB2C
- OfferingHardware or Manufacturing
What CEFALY does
CEFALY is a Wilton, Connecticut–based (per firmographics) privately held medical device company that sells an FDA-cleared, over-the-counter trigeminal nerve stimulation (eTNS) device for the acute treatment and daily prevention of migraine attacks. Its core technology delivers precise electrical pulses to the supraorbital branch of the trigeminal nerve via a self-adhesive forehead electrode, with two protocols: a 60-minute acute session and a 20-minute daily preventive session. Reported clinical outcomes include 79% of patients experiencing significant headache-pain reduction after one hour of acute treatment, 56% reporting resolution of their most bothersome symptom (nausea, vomiting, light/sound sensitivity) within two hours, and 38.1% achieving a 50%+ reduction in migraine days after three months of preventive use, backed by the ACME, TEAM, and PREMICE studies.
The product ecosystem centers on the CEFALY Device (standard OTC eTNS unit) and the CEFALY Connected variant, which pairs via Bluetooth magnetic connection with the CEFALY App on iOS and Android for session tracking and remote control. Recurring revenue is generated through replacement electrode pads sold as a subscription consumable, supplemented by paid one-on-one CEFALY Coaching Services that support onboarding and treatment optimization. The company operates a hybrid go-to-market: direct-to-consumer sales through a Shopify storefront (shop.cefaly.com), a Cefaly Certified provider channel that funnels clinician recommendations, and product-led growth via the connected app ecosystem. Region storefronts are live for the United States, Europe, Canada, and "Other" markets, with English, French, and Spanish localization, though the app and connected services are explicitly not yet available in the EU. Marketing is multi-channel—organic social across Facebook, Instagram, TikTok, YouTube, LinkedIn, and Pinterest, plus affiliate (Awin) and influencer (Grin) programs, and clinical endorsements such as Dr. Michael A. L. Johnson, MD in Neurology. The device is prescription-free and HSA/FSA eligible.
CEFALY firmographics
Firmographics- Name
- CEFALY
- Website
- https://cefaly.us
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Short description
- CEFALY sells an FDA-cleared, over-the-counter trigeminal nerve stimulation device for acute migraine relief and daily prevention, distributed direct-to-consumer via e-commerce and a certified clinician network, with recurring electrode subscriptions and coaching services for individual migraine sufferers.
- Ownership category
- akta.pro rank
CEFALY industry classification
Industry- Product category
- 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)
- akta.pro secondary industry
- Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE)
Keywords
Where CEFALY is headquartered
LocationHeadquarters
- HQ city
- Wilton
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
CEFALY business model
Business model- GTM type
- B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Marketing or Sales, Supply Chain, Technology or R&D, Operations, Personnel
Revenue model
- Hardware Device Sales: One-time purchase of the CEFALY migraine treatment device sold directly to consumers through e-commerce. Device is prescription-free and available for direct consumer purchase.
- Consumable Electrode Refills: Replacement electrodes (self-adhesive) sold as subscription or one-time purchase for ongoing device use.
- Coaching Services: Paid coaching sessions offered to help customers learn device usage and optimize migraine management.
Go-to-market motion3 records
Distribution channels4 records
Marketing channels6 records
CEFALY product offering
Product offeringCore offering
CEFALY manufactures and sells an FDA-cleared over-the-counter medical device that uses precise electrical pulses to stimulate the supraorbital branch of the trigeminal nerve through a self-adhesive electrode placed on the forehead. The device supports a 60-minute acute migraine treatment mode and a 20-minute daily prevention mode, and is complemented by a connected Bluetooth version, a companion mobile app, replacement electrode refills, and one-on-one coaching services.
Product overview
CEFALY offers a unified migraine treatment platform centered on its FDA-cleared trigeminal nerve stimulation device. The core product line includes the standard CEFALY Device for acute and preventive migraine treatment, the CEFALY Connected version with Bluetooth connectivity, and the companion CEFALY App for session tracking and device control. The ecosystem is supplemented by electrode accessories (available via subscription) and personalized coaching services. The company operates exclusively in the migraine treatment space, with all products designed to work together as an integrated migraine management solution.
Differentiator
Problem solved
Functional benefit
Products and services
- CEFALY Device FDA-cleared medical device that delivers precise electrical pulses to the trigeminal nerve via a self-adhesive electrode on the forehead to treat acute migraine attacks and prevent future migraines. Available without prescription for direct consumer purchase.
- CEFALY Connected Bluetooth-enabled version of the CEFALY device that pairs with the companion mobile app, allowing users to track treatment sessions, control device settings, and access their migraine history through a magnetic auto-aligning connection.
- CEFALY App Mobile application for iOS and Android that pairs with the CEFALY Connected device to track migraine patterns, control treatment sessions, and provide coaching support.
- CEFALY Electrodes Replacement self-adhesive electrode pads for the CEFALY device, available through a subscription service for convenient replenishment to support continued device use.
- CEFALY Coaching Services One-on-one paid coaching sessions that help users set up the CEFALY device, learn proper usage, and optimize their migraine management protocols.
Quantifiable outcome
- 79% of patients saw significant reduction in headache pain after one hour of Acute treatment
- +4 more outcomes
Companies that use CEFALY
Customer profileNamed customers3 records
Segments2 records
Ideal customer profiles2 records
CEFALY technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
CEFALY partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered minor.
- Awin (Affiliate Platform)minorAwin affiliate marketing platform used to manage CEFALY's affiliate partnerships for customer acquisition. The company runs an affiliate program to drive sales through third-party marketing partners.
- Grin (Influencer Platform)minorGrin influencer marketing platform used to manage CEFALY's influencer partnerships. The company collaborates with influencers in the migraine/health space to reach target customers.
Scale indicators1 record
Recent moves6 records
Expansion highlights6 records
CEFALY competitors and assessment
Company assessmentDirect peers
- Theranica Bio-Electronics: Maker of Nerivio, a FDA-cleared wearable remote electrical neuromodulation (REN) device worn on the arm for acute and preventive migraine. Direct competitor targeting the same migraine patient population via a non-pharmacologic, prescription-based or OTC-style connected device model.
- electroCore: Develops gammaCore, a non-invasive vagus nerve stimulation (nVNS) device for migraine, cluster headache, and related conditions. Closely comparable as a non-invasive neurostim competitor in the headache/migraine therapeutic area.
- eNeura: Maker of SpringTMS and now SAVI Dual, single-pulse transcranial magnetic stimulation (sTMS) devices prescribed for acute and preventive migraine. Directly competes with CEFALY in non-invasive, device-based migraine therapy with similar clinical positioning.
Emerging players
- Salvia BioElectronics: Dutch startup developing a thin, wearable patch for chronic migraine using bioelectronic neurostimulation. Emerging player pursuing the same preventive migraine use case with a differentiated thin-film form factor.
- Neurolief: Developer of Relivion, a wearable non-invasive brain neuromodulation headset for migraine and depression. Comparable as an emerging neuromodulation device aimed at the same headache/migraine clinical segment.
- Neuromod Devices: Developer of Lenire, a bimodal neuromodulation device (transcutaneous electrical and audio stimulation) for tinnitus. Comparable as a non-invasive, consumer-adjacent neuromodulation company building a clinical-evidence-driven, device-plus-consumables business model.
Broad incumbents
- Axonics Modulation Technologies: Public neuromodulation company commercializing implantable sacral and pudendal nerve stimulation systems. Operates broadly in the neurostimulation space with overlapping core technology (electrical nerve stimulation) but different indications and an implantable, surgical-channel model.
- Inspire Medical Systems: Established neuromodulation company marketing an implantable hypoglossal nerve stimulation device for obstructive sleep apnea. Comparable as a public, scaled neurostimulation incumbent with regulatory and clinical infrastructure CEFALY lacks, though targeting different indications.
Others
- Fisher Wallace (Brainstim Inc.): Sells a wearable cranial electrical stimulation (CES) device for insomnia, anxiety, and depression. Comparable as a non-prescription, direct-to-consumer neurostim device with overlapping go-to-market patterns (DTC, prescription-free consumer electronics style).
- AbbVie / Allergan (Ubrelvy / Botox): Markets oral CGRP inhibitor Ubrelvy (ubrogepant) and onabotulinumtoxinA (Botox) for chronic migraine. Comparable as a competitor for the same migraine patient pool via a different (pharmacologic) modality, shaping the competitive landscape for CEFALY's addressable market.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
CEFALY social profiles
Digital presenceCEFALY compliance and trust
Trust signalCompliance1 record
CEFALY financial estimates
Financial estimateRevenue estimate
Valuation estimate
CEFALY leadership team
Management profileNumber of profiles
CEFALY funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
CEFALY 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 CEFALY
What does CEFALY do?
CEFALY manufactures and sells an FDA-cleared over-the-counter medical device that uses precise electrical pulses to stimulate the supraorbital branch of the trigeminal nerve through a self-adhesive electrode placed on the forehead. The device supports a 60-minute acute migraine treatment mode and a 20-minute daily prevention mode, and is complemented by a connected Bluetooth version, a companion mobile app, replacement electrode refills, and one-on-one coaching services.
When was CEFALY founded?
CEFALY was founded in 2016.
Where is CEFALY based?
CEFALY is headquartered in Wilton, United States, in the North America region.
How does CEFALY make money?
Three revenue lines are on record. Hardware Device Sales are the primary driver. The others are consumable Electrode Refills and coaching Services.
Who are CEFALY's main competitors?
Direct peers on record are Theranica Bio-Electronics, electroCore and eNeura. Emerging players are Salvia BioElectronics, Neurolief and Neuromod Devices. Broad incumbents are Axonics Modulation Technologies and Inspire Medical Systems. Others are Fisher Wallace (Brainstim Inc.) and AbbVie / Allergan (Ubrelvy / Botox).
Does CEFALY have an API?
No public API is recorded for CEFALY.
What industry is CEFALY in?
CEFALY's product category is Neuromodulation Medical Devices. Its primary akta.pro industry code is HLAHAEAK, Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS), with a secondary code of HLAHACAE, Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables). Its NAICS code is 334510 and its SIC code is 3845.