Theranica has secured extended CE mark approval for Nerivio as a dual-use therapy for acute and preventive migraine treatment for adolescents and adults.
The self-administered therapy is controlled through a smartphone app. Nerivio wraps around the upper arm and employs sub-painful remote electrical neuromodulation (REN) for activating nociceptive nerve fibres in the arm.
This stimulation prompts the transmission of signals that initiate a descending pain management mechanism known as conditioned pain modulation (CPM) within the brain to stop migraine pain and its related symptoms.
Each treatment lasts 45 minutes and is given every alternate day for prevention, or when a migraine attack begins for acute treatment.
Since 2020, Nerivio has been available by prescription in the US. It was initially used for acute treatment and available as a preventive treatment since April this year.
Theranica CEO and co-founder Alon Ironi said: “We have been waiting for the prevention indication approval, and with that are now preparing for making Nerivio available for people with migraines in Europe starting 2024.
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“Our focus is to empower underserved populations, particularly adolescents, to safely and effectively prevent and treat migraines, and be fully present in everyday life.”
Migraine affects more than one billion individuals globally, with a prevalence exceeding one in every ten people in Europe.
Theranica, a prescribed digital therapeutics company, is focused on expanding its advanced technology to develop solutions for additional idiopathic pain conditions.