FDA grants De Novo clearance to smartphone-controlled acute migraine-relief device

Nerivio Migra, a first-in-category product, is placed on the upper arm (not the head or neck) and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response.
By Dean Koh
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An illustrated graphic of how the Nerivio Migra device works. Source: Theranica

Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced on May 28 that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilising Remote Electrical Neuromodulation for the acute treatment of migraine.

The FDA market authorisation is based on the results of a prospective, randomised, double-blind, placebo-controlled, multi-center pivotal study, where 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.

“This study followed the latest edition of the guidelines from the International Headache Society for controlled trials of acute treatment of migraine attacks in adults,” said Dr. Brian Grosberg, MD, director of the Hartford Healthcare Headache Centre in Connecticut, who served as the lead Principal Investigator (PI) of the study. “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,” explained Dr. Grosberg, who was a co-author of an article describing the study, released earlier this month in Headache: The Journal of Head and Face Pain published by Wiley Periodicals, Inc. on behalf of the American Headache Society.

Nerivio Migra, a first-in-category product, is placed on the upper arm (not the head or neck) and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response. Nerivio Migra is indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.

WHAT'S THE TREND

Earlier this month, Omron Ventures, the venture capital arm of Japan-based Omron Corporation and its affiliated companies, joined Theranica’s $35M Series B funding round as a strategic investor. The investment sum by Omron Ventures has not been disclosed. 

ON THE RECORD

“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 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.”

“Physicians who treat people with migraine are both patient-centered and science-driven,” said Prof. Stephen Silberstein, director of the Headache Centre at the Jefferson University Hospital in Philadelphia, a member of the medical advisory board of Theranica. 

“Over the last 20 years my colleagues and I have used triptans (migraine-specific medications) and ergots for acute migraine treatment. There is a large unmet need for new treatments in this population when these medications are not effective, are contra-indicated, or have non-tolerable side effects. In addition, triptans and most current acute migraine medications, including over-the-counter drugs indicated for migraine, are associated with medication-overuse headache (MOH), which is associated with increased frequency of migraine attacks, and often results in chronic migraine. This new innovative FDA-authorised treatment is an important alternative to help our patients control this debilitating condition.”