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.
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.”
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.