Nerivio® CE mark indication expanded to preventive and acute treatment of migraine for adolescents and adults
The company prepares for bringing the wearable prescribed device to Europe next year
NETANYA, Israel, Aug. 9, 2023 /PRNewswire/ — Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, today announced it received expanded CE (Conformité Européenne) mark approval under MDR European regulation for Nerivio® as dual-use therapy for both acute and preventive treatment of migraine for adults and adolescents. The CE mark expansion for Nerivio is a critical milestone to accelerate the availability of the novel, drug-free migraine device into the European market.
Migraine is a major global neurological disorder that affects over 1 billion people worldwide, with a prevalence higher than one in ten people in Europe. Research shows it’s one of the most prevalent disorders, with a high morbidity, especially among young adults and females.
Nerivio has been available with prescription in the USA since 2020, initially for acute treatment and since April this year also as a preventive treatment.
“Migraine is the leading cause of disability worldwide, including for for adolescents and young adults, and early intervention with preventive treatment is necessary to restrain the disease from escalating”, said Dr. Simona Sacco, Professor of Neurology at the University of L’Aquila, Italy, and second vice president of the European Headache Federation. “It is important to expand the treatment options with a non-pharmacological treatment, especially one that can both treat and prevent migraine.”
“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,” says Alon Ironi, CEO and co-founder of Theranica. “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.”
Controlled by a smartphone app and self-administered, Nerivio wraps around the upper arm and uses sub-painful Remote Electrical Neuromodulation (REN) to activate nociceptive nerves fibers in arm to send signals which trigger a descending pain management mechanism in the brain called conditioned pain modulation (CPM), which turns off migraine pain and 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. Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment.