FDA expands clearance of Theranica's neuromodulation armband for migraine

A wearable device from Theranica Bio-Electronics that was cleared by the FDA in 2019 to ease the symptoms of migraine may now take a much more proactive approach to that treatment.

Just a few months after the company submitted a new 510(k) application to the regulator requesting an expanded indication for the technology, the FDA has granted its wish. The prescription-only Nerivio neuromodulation armband can now be used not only to treat migraine symptoms after onset, but also to prevent the headaches from coming on at all, Theranica announced this week.

The device’s preventive use was cleared for people who experience migraines with or without aura and who are at least 12 years old. That’s the same age group as those cleared for Nerivio’s acute treatment indication, which was initially greenlighted for use only in adults before seeing its label expand about two years later.

To use the Nerivio device, patients wrap the armband around their upper arm and use a connected smartphone app to start and stop the treatment and control its intensity.

Throughout each treatment session, electrodes embedded in the armband emit electrical pulses to nearby peripheral nerves. Though not designed to be physically painful to the wearer, those pulses are meant to trigger internal pain management mechanisms, with the resulting pain relief spreading throughout the nervous system to reach the brain.

That approach has already been proven as a valid acute treatment for migraine, and a new study published last year showed that stimulating pain relief across the nervous system even before a migraine has set in can stop it from doing so at all.

The study recruited about 250 people, split between those with chronic and episodic migraines. After eight weeks of treatment, those assigned to use the Nerivio armband saw their average migraine days drop by an average of four days per month compared to a reduction of just 1.3 days in the placebo group. People with chronic migraines experienced a slightly stronger benefit from the device than those with episodic cases, with average monthly reductions of 4.7 days and 3.2 days, respectively.

For preventive purposes, Theranica recommends that 45-minute treatments be administered every other day, though users have full control over their own regimens.

In an interview with Fierce Medtech last year after the release of the study results and the new FDA submission, CEO Alon Ironi said allowing the Nerivio technology to be used for both prevention and acute treatment would make it a “much more important and impactful therapy.”

“That means, first of all, less dependency on pharmacological agents. It also means less burden, because if you only have one therapy that you have to adhere to, it’s fewer things to worry about,” Ironi said. “If you manage to get both significant reduction in your migraine episodes as well as to abort whatever episodes you do experience with the same therapy, that makes your life easier.”

With the dual-use indication now in hand, Theranica has also expanded the device’s neurostimulation capacity: Each Nerivio unit can now be used for 18 treatment sessions, compared to a previous threshold of 12. The units are listed at $599, but with insurance coverage and Theranica’s savings program, the copay can drop to as low as $10 for the first unit and $49 for refills, per the company.