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A Game Changing First Line Treatment for Migraines

FDA Cleared (prescription required), CEFALY is a clinically proven, drug-free treatment for acute and preventative relief from migraine pain.

2 Billion

migraines treated since 2008

350,000

devices sold worldwide

CEFALY device image
The CEFALY DUAL neuromodulator (e-TNS) is the first FDA Cleared (prescription required) medical device of its kind for the treatment of migraine.

CEFALY DUAL is indicated to be used for:

  • Acute treatment of migraine with or without aura in patients 18 years of age or older.
  • Preventative treatment of episodic migraine with in patients 18 years of age or older.

CEFALY is ideal for people with migraine who:

  • Don’t respond to pharmaceutical treatments or seek clinically proven effective alternatives to pharmaceuticals.
  • Have prior medical conditions and are unable to take traditional pharmaceuticals.
  • Have limited access to outpatient treatment procedures.

CEFALY blocks migraine pain and provides relief during attacks

In a double-blind, randomized, sham-controlled study conducted across multiple headache centers in the U.S. patients saw a reduction in migraine pain intensity following a 60-minute ACUTE treatment session with CEFALY.

  • An average 59% reduction in migraine pain intensity following one hour of treatment with CEFALY. This relief continued up to 24 hours.
  • 79% of Acute migraine sufferers saw pain relief.
  • 32% of Acute migraine sufferers saw pain freedom.
  • No adverse events reported.

Chou D. E. et al. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2019; 39(1): 3-14.

CEFALY significantly reduces number of migraine days

In a double-blind, randomized, sham-controlled study conducted across multiple Belgian tertiary headache centers patients with compliant daily use of CEFALY 20-minute PREVENT treatment experienced a significant reduction in number of migraine days.

  • Mean 2.06 (30%) reduction in migraine days in verum group.
  • 38.1% of CEFALY users saw at least 50% reduction in number of migraine days.
  • Adverse events were mild and fully reversible within 20 minutes, without intervention.

PREMICE STUDY Migraine prevention with a supraorbital transcutaneous stimulator. A randomized controlled trial. Jean Schoenen, Bart Vandersmissen, Sandrine Jeangette, Luc Herroelen, Michel Vandenheede, Pascale Gerard, Delphine Magis. Neurology Feb 2013, 80 (8) 697-704; DOI: 10.1212/WNL.0b013e3182825055

CEFALY DUAL clinical trials have shown side effects to be minor and fully reversible.

Most Common (5% of users)

  • Intolerance
  • Mild Sedative Effect
  • Allergic Contact Dermatitis

Less Common (2-5% of users)

  • Headache
  • Persistent Sensation
  • Neck Muscle Tightness

Rare (<2% of users)

  • Nausea
  • Tinnitus
  • Tooth Pain
  • Hyperlacrimation