Israeli Device Gets FDA Approval For Migraine Treatment In Adolescents

Israeli digital therapeutics firm Theranica, a developer of advanced electroceuticals for migraine and other pain conditions, announced on Monday that its Nerivio therapeutic device has received clearance from the US Food and Drug Administration to market its device for the acute treatment of episodic or chronic migraine in people 12 years and older.

Founded in 2015, Theranica combines electrical neurostimulation and neuromuscultar-stimulation technologies with modern wireless communication and smartphone applications The company leverages these advanced technologies to design and deliver effective products for treating a variety of severe and common medical problems.

Theranica’s Nerivio Migra, which won FDA De Novo clearance in May 2019,  is a migraine-relief patch that provides migraine treatment through neuromodulation. Patients can attach Theranica’s clinically tested, wearable patch on their upper arm for up to 45 minutes and launch a personalized pain-relief program.

Nerivio was featured on Time Magazine’s list of 100 Best Innovations in 2019, alongside eight other Israeli innovations.

The use of the device in the treatment of adolescents is supported by a study recently published in the journal Headache. According to the study, 71 percent of the adolescent participants using Nerivio experienced pain relief after two hours while 35 percent experienced complete freedom from pain. Pain relief and pain freedom were sustained for 24 hours in 90 percent of cases. 69 percent of the patients experienced an improvement in their functional ability, defined by the ability to do schoolwork and perform “usual activities,” at two hours. There were no device-related serious adverse events.

“This new indication is a dramatic step in our committed effort to serve the migraine community as a whole,” said Theranica’s CEO and co-founder Alon Ironi. “Throughout 2020, we continued pursuing clinical data regarding how Nerivio can help this all-too-large patient population. As a result, Nerivio is now widely available as a drug-free alternative to treat migraine. Teens are one of the most vulnerable migraine populations and we are happy to provide them with a user-friendly tool to get them back to their daily lives as quickly as possible.”

Nerivio is available by prescription by licensed healthcare providers including via telemedicine platforms such as Cove and UpScript. Every Nerivio unit is good for 12 treatments, after which it can be recycled, and the prescription refilled with a new device.