The Nerivio Migra uses smartphone-controlled electrical pulses to create a Conditioned Pain Modulation (CPM) response. Credit: PRNewsfoto/Theranica Bioelectronics.

Israel-based Theranica Bioelectronics has received de novo approval from the US Food and Drug Administration (FDA) for a smartphone-controlled wearable device to help treat acute migraines.

Named Nerivio Migra, the electroceutical uses remote electrical neuromodulation and can be attached to the patient’s upper arm for a personalised pain relief programme.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The wearable device comprises electrodes, a battery and Theranica’s smart chip, which generates electrical pulses to stimulate the sensory nerves under the skin and create conditioned pain modulation (CPM).

Designed for the acute treatment of adult patients who do not have chronic migraines, Nerivio Migra can be controlled using an intuitive smartphone application.

Theranica CEO and co-founder Alon Ironi said: “While the company is preparing to launch the Nerivio Migra in the US 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.”

The FDA decision is based on data obtained from a prospective, randomised, double-blind, placebo-controlled, multi-centre pivotal study that involved 252 patients at 12 clinics.

According to the company, data showed a 66.7% pain relief response within two hours.

Study principal investigator Dr Brian Grosberg said: “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.”

“The company is preparing to launch the Nerivio Migra in the US market later this year at an affordable price.”

Migraine attacks are the third most common disease and are known to affect 14.7% of the global population. In the US alone, the condition costs $17bn annually.

Founded in 2016, Theranica is focused on developing wireless neuromodulation technologies.

The company has identified seven different painful disorders that could be potentially addressed with non-invasive, drug-free electroceuticals.