Theranica announced today that it received CE Mark approval for its Nerivio device for the acute treatment of migraine.
Montclair, N.J.-based Theranica adds European approval just over a year since it received FDA de novo clearance for the neurostimulation device in May 2019. The approval allows for the company to begin marketing the device in 2021 under the new MDR European regulation, according to a news release.
The wearable, smartphone-controlled device is placed on the upper arm at the onset of a migraine attack and uses remote electrical neuromodulation to stimulate a conditioned pain modulation response for pain mitigation.
Additionally, the device has a corresponding phone app to keep track of migraine episodes, offering analytics that allow the patient and a doctor to monitor and tailor specific treatments.
“Nerivio combines clinical efficacy comparable to prescription drugs, with a high safety profile,” Theranica CEO Alon Ironi said in the release. “After its successful launch in the U.S., Nerivio will soon provide European migraine patients with the option of a non-pharmacological treatment that can keep them safe from medication overuse headache.
“The ease of use, focused on rapid return to normal functioning, combined with the digital health emphasis as a smartphone-controlled wearable, is a fresh addition to the arsenal of migraine therapies.”