|eNeura's Cerena TMS--Courtesy of eNeura|
California's eNeura won FDA approval for its portable migraine-fighting device, heading to the U.S. market with a transcranial magnetic stimulation tech that can relieve pain in some of the most extreme cases.
The device, called Cerena TMS, is designed to treat migraines that are preceded by a sensory disturbance, using a magnetic pulse to stimulate the brain's occipital cortex and alleviate pain. In a pivotal trial on 201 patients, nearly 38% of migraine sufferers who used Cerena TMS were pain-free two hours after onset compared to about 17% in the control group, and nearly 34% of those in the treatment arm stayed that way after 24 hours, besting the 10% rate of the control segment, the FDA said.
Roughly 10% of people suffer from migraines, according to the agency, and one-third experience sensory disruptions beforehand. Cerena TMS is already CE marked and commercially available overseas, and now, with the FDA's blessing, eNeura can hit the ground running with a U.S. launch.
ENeura is the first to win FDA approval for a migraine-treating TMS application, but the company is hardly alone in finding a therapeutic angle in what was once only an imaging technology. Israel's Brainsway won FDA approval in January for Deep TMS, using a similar mechanism to treat depression. Neuronetics has a CE-marked device that works the same way, and Cervel Neurotech raised $14.1 million this year to develop a TMS system for chronic pain.
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