Not to be outdone by the FDA, regulators in Europe have given the all-clear to a new indication for Theranica’s neuromodulation armband for migraine treatment.
The nod extends the Nerivio system’s existing CE mark, which was granted in 2020 and allowed the technology to be used in Europe for acute relief of migraine symptoms. It comes just a few months after the FDA granted a similar expansion to Nerivio’s indications for use in the U.S., where it first earned the acute use nod in 2019.
In addition to its acute treatment indications, the system can now be used as a preventive tool in both regions. As with the updated FDA clearance earlier this year, the CE mark extension applies to both adults and teenagers who experience migraines.
And while Theranica began rolling out Nerivio in the U.S. in 2020, when it was still cleared only as an acute migraine treatment, it held back on the European launch—until now.
“With more than 50,000 prescribed Nerivio patients now in the U.S., we receive numerous requests, on a weekly basis, to bring the device to Europe,” CEO Alon Ironi said in the company’s announcement Wednesday. “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.”
The Nerivio system works by stimulating peripheral nerves in the arm, with a goal of triggering pain management mechanisms in the nervous system that can relieve headache and the other painful symptoms of migraines. It’s designed to offer a drug-free alternative to many other currently available migraine treatments.
To use the system, individuals wear a band that wraps around the upper arm. The armband holds a device that’s embedded with electrodes to emit what Theranica describes as “sub-painful” electrical pulses to the nearby nerves. Each treatment session lasts 45 minutes and is completely controlled through a connected app on a user’s own smartphone.
Users can start the neurostimulation sessions as soon as a migraine sets in to help ease the symptoms, or the sessions can be conducted every other day as a preventive measure to ward off migraines before they even begin, according to Theranica.
In a study of Neirivio’s use as a preventive tool for migraine, after eight weeks of consistent usage, participants reported an average of four fewer migraine days per month, compared to a 1.3-day reduction among a placebo group, according to results reported last fall.
The improvement was especially pronounced among people with chronic migraine, compared to those with episodic cases. Their improvements came out to an average drop of 4.7 and 3.2 migraine days per month, respectively.
Plus, in what Ironi described to Fierce Medtech at the time as something of a surprise for the company, the benefits also carried over through the 40% of participants who were actively using other tools to treat their migraine symptoms, including prescribed oral medications, monoclonal antibody injections and Botox injections; they experienced 3.5 fewer migraine days per month, compared to 1.5 in their placebo counterparts.