Theranica, an Israeli-based bio-medical technology company based in Netanya, has received FDA De Novo request for its Nerivio Migra® smartphone-controlled wearable device, which uses Remote Electrical Neuromodulation to treat acute migraine.
Migraine affects about 14.7 percent of the world ‘s population, making it the world’s third most prevalent disease.
However, both patient-centered and science-driven physicians who treat people with migraine are. Doctors are using medications such as triptans and ergots for treating acute migraine. But when these medications are not effective, are contra-indicated, or have non-tolerable side effects, there is a huge need for new treatments for migraines.
“The clinical data of this innovative therapeutic device is of very high quality,” commented Professor Messoud Ashina, Danish Headache Center, International Headache Society’s president-elect. “It means that the system will provide patients with substantial pain relief and other migraine symptoms without the drug-induced side effects.”
FDA’s de novo classification acts as an alternate means of classifying devices which are low to moderate in risk. Thus devices listed by the de novo process can be sold and used as predicates for potential 510(k) submissions.
Nerivio Migra was approved by the FDA based on the findings of a retrospective, randomized, double-blind , placebo-controlled, multicenter pivotal study, where 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks, says a press release.
“This study followed the latest version of the International Headache Society recommendations for controlled trials of acute treatment of migraine attacks in adults,” said Dr. Brian Grosberg, MD , director of the Connecticut Hartford Healthcare Headache Center, who served as the study’s lead Principal Investigator. “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 the journal Headache.
The unit is mounted on the upper arm (not the head or neck) and uses electronic stimuli powered by the smartphone to generate a response to Conditioned Pain Modulation (CPM). Nerivio Migra ® is intended for the acute treatment of migraine in adult patients without chronic migraine, with or without aura.
Alon Ironi, Theranica ‘s CEO and co-founder said his firm is committed to expanding the use of remote electrical neuromodulation therapy for additional indications. “We have described at least 7 different painful conditions that can be eased after sufficient clinical development by this non-invasive, drug-free technology,” Ironi said.
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