Nerivio Migraine Device Snags Expanded CE Mark

Theranica, which develops advanced neuromodulation devices for migraines and other pain conditions, has now obtained expanded CE mark approval for its Nerivio device as a dual-use therapy for both acute and preventative treatment of migraines for adults and adolescents.

The Nerivio device wraps around the upper arm, is controlled by a smartphone, and self-administered. It uses sub-painful remote electrical neuromodulation (REN) to activate nociceptive nerve fibers in the arm that send signals which trigger a descending pain management mechanism in the brain called conditioned pain modulation (CPM). These signals turn off migraine pain and the associated symptoms without medication.

“In simpler terms, the upper arm is stimulated to unleash a natural process in the brain to abort or relieve migraine headache and other associated symptoms,” according to the press release announcing the CE mark.

Each Nerivio treatment lasts 45 minutes and can be applied every other day for prevention care or at the start of a migraine for acute treatment.

The device has been available in the US since 2020 for acute treatment and, in April 2023, was also approved for preventative treatment. According to Theranica, the next step is to make Nerivio available in Europe, which they hope to accomplish in 2024.

"With more than 50,000 prescribed Nerivio patients now in the US, we receive numerous requests, on a weekly basis, to bring the device to Europe," said Alon Ironi, CEO and co-founder of Theranica, in the press release. "We have been waiting for the prevention indication approval, and with that are now preparing for making Nerivio available for people with migraine in Europe starting 2024. Our focus is to empower underserved populations, particularly adolescents, to safely and effectively prevent and treat migraines, and be fully present in everyday life."