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The device sends smartphone-controlled electronic pulses to create a conditioned pain modulation response.
Photo/Thumb have been modified. Courtesy of Theranica.
The U.S. Food and Drug Administration (FDA) granted a De Novo request for Theranica’s smartphone-controlled electroceutical that uses remote electrical neuromodulation for the acute treatment of migraines, according to an announcement.
The Israeli biomedical technology company’s product, Nerivio Migra, attaches to the upper arm and uses smartphone-controlled electronic pulses to create a conditioned pain modulation response.
The FDA market authorization is based on the results of a prospective, randomized, double-blind, placebo-controlled, multi-center pivotal study.
In the study, published in Headache: The Journal of Head and Face Pain, 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.
The research team placed participants in an active or sham stimulation group. Participants in the study had two to eight migraine headaches per month.
A participant wore the smartphone-controlled wireless device for 30 to 45 minutes on the upper arm within one hour of the attack onset.
Researchers measured migraine levels at baseline, two and 48 hours after treatment. The research team also recorded bothersome symptoms.
Two hours after treatment, active stimulation showed higher effectiveness in achieving pain relief (66.7%) than the sham stimulation (38.8%). Active stimulation also led to more bothersome symptom relief at 46.3% compared to 22.2%. Participants who used the device sustained pain relief and pain-free superiority 48 hours after treatment.
Alon Ironi, CEO and co-founder of Theranica, said the company is preparing to launch the product in the U.S. market later this year. He said Theranica will remain committed to continuing its clinical development and expanding the use of remote electrical neuromodulation therapy for additional indications.
“We have identified at least seven painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development,” Ironi said.
In the U.S., migraine results in $17 billion in annual health costs. But a majority of patients suffering from migraines delay or avoid taking their prescription medication due to concerns about adverse side effects, according to a study published in Headache: The Journal of Head and Face Pain.
“This new innovative FDA-authorized treatment is an important alternative to help our patients control this debilitating condition,” said Stephen Silberstein, M.D., director of the Headache Center at the Jefferson University Hospital in Philadelphia.
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