Cefaly

Executive Summary

Cefaly Technology is a Belgian medical device company specializing in a drug-free, wearable neuromodulation device for migraine. Its flagship product, CEFALY, is FDA-cleared for both acute treatment and prevention of migraine in adults, using external trigeminal nerve stimulation (e-TNS). As an over-the-counter solution, CEFALY offers a non-invasive alternative to pharmaceuticals, appealing to the large and underserved migraine market. The company is privately held, with a focus on expanding its clinical evidence base and commercial reach. With migraine affecting over 1 billion people globally and a growing preference for non-pharmacological therapies, Cefaly is well-positioned for growth. The device's unique mechanism, safety profile, and OTC status provide a competitive edge in the neuromodulation space. Future success hinges on broadening indications, securing reimbursement, and scaling distribution, particularly in the U.S. and Europe.

Upcoming Catalysts (preview)

• Q3 2026Positive Phase 3 trial results for acute migraine treatment70% success
• Q1 2027FDA clearance for pediatric migraine indication60% success
• Q2 2026Strategic distribution partnership with major pharmaceutical company50% success