Nerivio Migra is a smartphone-controlled electroceutical device that uses remote electrical neuromodulation for the acute treatment of migraine.
The approval was based on data from the prospective, randomized, double-blind, placebo-controlled and multi-center pivotal study. Theranica recruited 252 patients at 12 clinics to use the non-invasive wearable for the treatment of their migraine attacks.
The study lead principal investigator Dr Brian Grosberg said: “This study followed the latest edition of the guidelines from the International Headache Society for controlled trials of acute treatment of migraine attacks in adults.
“The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at two and 48 hours after treatment,”
Nerivio Migra is a first-in-category product, which will be placed on the upper arm and uses smartphone-controlled electronic pulses to create a conditioned pain modulation (CPM) response.
The device has been developed for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.
Migraine is said to be the third most common disease in the world with an estimated global prevalence of 14.7% of the world’s population and migraine results in $17bn of annual health costs in the US alone.
Theranica CEO and co-founder Alon Ironi said: “While the company is preparing to launch the Nerivio Migra in the United States market later this year at an affordable price, we remain committed to continuing our clinical development, expanding the use of remote electrical neuromodulation therapy for additional indications.
“We have identified at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development.”
Established in 2016, Theranica combines advanced neuromodulation therapy with modern wireless technology for the development of proprietary electroceuticals to treat prevalent medical conditions and diseases.
The company intends to apply its proprietary technology for the development of additional solutions to other painful disorders.
