The United States Food and Drug Association (FDA) has reportedly granted De Novo clearance for Theranica’s Nerivio Migra, the first-ever Smartphone controlled wearable device for acute care of migraines. The device, worn on the upper arm, leverages remote electrical neuromodulation for the acute treatment of migraine that is proven to be as efficient as leading devices and drugs on the market in treating acute migraine, and it’s all happen with fewer and milder side effects.
According to a report, migraine is the third most common disease in the world, which estimated global prevalence is 14.7 percent of the world’s population. Moreover, this kind of disease results in USD17 billion of annual health costs in the U.S. alone. With 2,444 people’ study who are suffering from migraine, a study found that two-thirds of them delayed or avoided taking their prescription medications due to adverse side effects, while 79 percent cited products with similar efficacy but fewer side effects. However, the FDA market authorization is based on the results of a prospective, randomized, double-blind, placebo-controlled, multi-center pivotal study, where 252 patients from 12 clinics utilized the non-invasive wearable device to treat their migraine attacks.
Theranica’s Nerivio Migra, a first-in-category product, is worn on the upper arm and user can control it with a Smartphone to create a Conditioned Pain Modulation (CPM) response. It is then indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine. Theranica CEO and co-founder Alon Ironi said that “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.” Ironi further added that “We have identified at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development.”