Theranica, a company based in Israel, won FDA De Novo clearance for its Nerivio Migra smartphone-operated electroceutical device for treating migraine headaches.
The device is worn around the upper arm, from where it delivers electronic pulses into the skin to generate a so-called “Conditioned Pain Modulation” response. This helps to mitigate the effects of a migraine in patients with or without aura, and is indicated for those who do not have chronic migraine. An accompanying smartphone app is used to control the settings of the therapy device, as it only has a power button of its own.
The De Novo clearance, putting the device in a category of its own, was the result of a prospective, randomized, double-blind, placebo-controlled, multi-center pivotal study involving 252 patients at a dozen different clinics. The study showed that the Nerivio Migra showed a “high efficacy ratio for single as well as multiple attacks, both at two and 48 hours after treatment,” according to Dr. Brian Grosberg, MD, director of the Hartford Healthcare Headache Center in Connecticut, and lead Principal Investigator of the study.
The device is expected to be made available in the United States later this year for acute treatment of migraines, and Theranica expects that its technology will also be made available to treat other types of pain. “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,” said Alon Ironi, CEO and co-founder of Theranica, in a published statement. “We have identified at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development.”
Product page: Nerivio Migra
Study of the Nerivio Migra in Headache: The Journal of Head and Face Pain: Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double‐Blind, Placebo‐Controlled, Multicenter Trial