Theranica has secured expanded Conformité Européenne (CE) mark approval for Nerivio as dual-use therapy for acute and preventive treatment of migraine in adults and adolescents.

The Israel-based digital therapeutics company Theranica received the CE mark under European Medical Devices Regulation (MDR).

Nerivio is a self-administered migraine bioband that can be controlled by a smartphone app. It is designed to be wrapped around the upper arm and employs sub-painful Remote Electrical Neuromodulation (REN) to activate nociceptive nerve fibres in the arm.

According to the digital therapeutics firm, REN helps in sending signals that activate a descending pain management mechanism in the brain known as conditioned pain modulation (CPM). This relieves migraine pain and associated symptoms without the use of medication, said the company.

Every treatment spans 45 minutes and is advised for usage on alternate days to prevent migraines or at the onset of an attack for immediate relief.

Additionally, the Nerivio app allows users to personalise their migraine treatments, get reminders for preventive therapies, follow their migraine patterns, and have the option to share migraine data with their doctors.

Theranica CEO and co-founder Alon Ironi said: “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.

“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.”

The CE mark expansion for Nerivio is expected to expedite the availability of the drug-free migraine device in the European market.

The self-administered bioband has already received the US Food and Drug Administration (FDA) clearance to treat migraine.